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Orphan Drug Designations and Approvals List as of 12 01 2016‐ ‐Governs January 1, 2016 March 31, 2016‐

Row Num Generic Name Trade Name Designation Date Designation Contact Company

1

ascorbic acid n/a 5/11/2009 Murigenetics SAS2

budesonide n/a 12/20/20063

n/a 9/11/2014 Lung Therapeutics, Inc.4

n/a 10/12/20115

n/a 6/5/2013 EMD Serono6

n/a 3/9/2012

Treatment of Charcot-Marie-Tooth disease type 1A.

Treatment of patients with eosinophilic esophagitis

Shire ViroPharma Incorporated

single chain urokinase plasminogen activator

Treatment of empyema (pleural)

(-)-(3aR,4S,7aR)-4-Hydroxy-4-m-tolylethynyl-octahydro-indole-1-carboxylic acid methyl ester

Treatment of Fragile X syndrome

Novartis Pharmaceuticals Corp.

(1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-broethyl) diamidophosphate

Treatment of pancreatic cancer

(1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-bromoethyl) diamidophosphate

Treatment of soft tissue sarcoma

Threshold Pharmaceuticals, Inc.



7

n/a 6/23/2015 Pfizer, Inc.8

n/a 2/17/2009 Pfizer, Inc.9

n/a 8/13/200410

n/a 1/29/2004

(1OR)-7-amino-12-fluoro-2,10,16-trimethyl-15 oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo[4,3-h][2,5,11]benzoxadiazacyclotetradecine-3-carbonitrile

Treatment of anaplastic lymphoma kinase (ALK)-positive or ROS1-positive non-small cell lung cancer

(1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-

Treatment of vaso-occlusive crisis in patients with sickle cell disease.

(1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-imino-D-ribitol-hydrochloride

Treatment of acute lymphoblastic leukemia

Mundipharma Research Limited


Treatment of T-cell non-Hodgkin's lymphoma

Mundipharma Research Limited



11

n/a 8/10/200412

n/a 9/15/2010


Treatment of chronic lymphocytic leukemia and related leukemias to include prolymphocytic leukemia, adult T-cell leukemia, and hairy cell leukemia

Mundipharma Research Ltd.

(1S,3S)-3-amino-4-(difluoromethylene)cyclopentanecarboxylic acid hydrochloride, (1S,3S)-3-amino-4-difluoromethylenyl-1-cyclopentanoic acid hydrochloride

Treatment of infantile spasms.

Catalyst Pharmaceuticals, Inc.



13

n/a 6/23/2014 Cortice Biosciences, Inc.14

n/a 10/14/201515

n/a 12/2/2010 QLT Inc.

(2'R,3'S)-2'-hydroxy-N-carboxy-3'-amino-5'-methyl-hexanoic,N-tert-butyl ester, 13 ester 5B-20-epoxy-1B,2a,4a,7B,9a,10a,13a-heptahydroxy-4,10-diacetate-2-benzoate-(1"S)-7,9-acrolein acetal-11(15-1)-abeotaxane

Treatment of progressive supranuclear palsy

(2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1h-pyrazolo [4,3-c] pyridine-3,6(2h,5h)-dione)

Treatment of systemic sclerosis.

Genkyotex Innovation SAS

(2E, 4E, 6Z, 8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-l-yl) nona-2,4,6,8-tetraen-l-yl acetate

Treatment of retinitis pigmentosa



16

n/a 12/2/2010 QLT, Inc.17

n/a 10/31/2012 Albireo AB

(2E,4E,6Z,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-enyl)nona-2,4,6,8-tetraenyl acetate 9-cis-retinyl acetate (API)

Treatment of Leber congential amaurosis (LCA) due to inherited mutations in RPE65 (encoding the protein retinal pigment epithelial protein 65) or LRAT (encoding the enzyme lecithin:retinol acyltransferase)genes.

(2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid

Treatment of progressive familial intrahepatic cholestatis



18

n/a 10/31/2012 Albireo AB19

Fk778 1/10/2005 Fujisawa Healthcare, Inc.20

n/a 3/18/2011 NATCO Pharma Limited21

n/a 3/18/2011 NATCO Pharma Limited

(2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid

Treatment of primary biliary cirrhosis

(2Z)-2-cyano-3-3hydroxy-N-[4-(trifluoromethly)phenyl]-2-hepten-6-ynamide

Prevention of acute rejection following kidney, heart, and liver transplantation

(3,5-Bis trifluoromethyl)-N-[4-methyl-3-(4-pyridin-3yl-pyrimidin-2-yl amino) phenyl] benzamide


(3,5-Bis trifluoromethyl)-N-[4-methyl-3-(4-pyridin-3yl-pyrimidin-2-yl amino) phenyl] benzamide

Treatment of chronic myelogenous leukemia.



22

n/a 3/18/2011 NATCO Pharma Limited23

n/a 4/30/2014 VivoLux AB24

n/a 9/11/2014 Genzyme25

n/a 8/26/2014 Genzyme Corporation26

n/a 7/5/2007

(3,5-Bis trifluoromethyl)-N-[4-methyl-3-(4-pyridin-3yl-pyrimidin-2-yl amino) phenyl] benzamideNRC-AN-019

Treatment of Glioma

(3E,5E)-3,5-bis[(4-fluoro-3-nitrophenyl)methylidene]-1-(prop-2-enoyl)azepan-4-0ne

Treatment of multiple myeloma

(3S)-1-azabicyclo[2.2.2]oct-3-yl {2-[2-(4-fluorophenyl)-1,3-thiazol-4-yl]propan-2-yl}carbamate

Treatment of Gaucher disease

(3S)-1-azabicylo[2.2.2]oct-3yl {2-[2-(4-fluorophenyl)-1,3-thiazol-4-yl]propan-2-yl}carbamate

Treatment of Fabry's disease

(3S)-3-(4-trifluoromethoxybenzyloxy)-6-nitro-2H-3,4-dihydroimidazo[2,1-b]oxazine

Treatment of tuberculosis

Global Alliance for TB Drug Development



27

n/a 8/19/200328

n/a 9/18/2015 AbbVie, Inc.29

n/a 9/4/2013

(3S)-3-[(2S)-2-({N-[2-tert-butyl)phenyl]carbamoyl}carbonylamino) propanoylamino]-4-oxo-5-(2,3,5,6-tetrafluorophenoxy) pentanoci acid

Treatment of patients undergoing solid organ transplantation.

Pfizer Global Research and Development

(3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide (2R,3R)-2,3-dihydroxybutanedioate

Treatment of pediatric (0 through 16 years of age) juvenile idiopathic arthritis (JIA) categories excluding systemic JIA

(4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-l-azoniabicyclo[2.2.2]octane Chloride

Treatment of progressive familial intrahepatic cholestasis

Shire Human Genetic Therapies, Inc.



30

n/a 9/4/201331

n/a 9/4/2013


Treatment of primary sclerosing cholangitis







32

n/a 9/4/201333

n/a 7/24/201334

n/a 2/21/2014 DARA BioSciences, Inc.35

n/a 6/29/2011 CytRx Corporation


Treatment of alagille syndrome


(5R)-5-(4-{[2-fluorophenyl)methyl]oxy}phenyl)-L-prolinamide, hydrochloride

Treatment of trigeminal neuralgia

Convergence Pharmaceuticals Ltd.

(6-[4-Deoxy-4-[(2E,4E)-tetradecadienoylglycyl] amino-L-glyceroB-L-manno-heptopyranosyl]amino-9H-purine)

Parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics

(6-maleimidocaproyl)hydrazone of doxorubicin




36

Cofactor 8/13/200437

n/a 10/13/201538

n/a 6/10/201539

n/a 12/8/200440

Ex-Rad(R) 6/1/2012

(6R,S)5,10-methylene-tetrahydrofolic acid

For use in combination with 5-fluorouracil for the treatment of patients with pancreatic cancer

Adventrx Pharmaceuticals, Inc.

(6aR, 10aR)-3-(1’,1’-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid

Treatment of cystic fibrosis.

Corbus Pharmaceuticals, Inc.

(6aR, 10aR)-3-(1â¿¿,1â¿¿-dimethylheptyl)-Î¿8-tetrahydro-cannabinol-9-carboxylic acid

Treatment of systemic sclerosis

Corbus Pharmaceuticals, Inc.

(9-[N-(3-morpholinopropyl)-sulfonyl]-5,6-dihydro-5-oxo-11-H-indeno [1,2-c] isoquinoline methanesulfonic acid

Prevention of post-operative complications of aortic anuerysm surgical repair

Inotek Pharmaceuticals Corporation

(E)-4-carboxystyryl-4-chlorobenzyl-sulfone, sodium salt

Prevention of acute radiation toxicity, also known as Acute Radiation Syndrome (ARS)

Onconova Therapeutics, Inc.



41

Ex-Rad(R) 9/4/201242

n/a 3/9/2012 Atterocor, Inc.43

n/a 4/24/201444

n/a 4/15/2011

(E)-4-carboxystyryl-4-chlorobenzyl-sulfone, sodium salt

Treatment of acute radiation syndrome


(N-[2,6-bis(1-methylethyl)-pheyl-N'-[[1-4-dimethyl-amino)phenyl]cyclopentyl]methyl]urea, hydrochloride salt

Treatment of adrenocortical carcinoma

(R)-1-(2,2-difluorobenzo [d][1,3] dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl) cyclopropanecarboxamide

Treatment of cystic fibrosis

Vertex Pharmaceuticals Inc.

(R)-1-phenylethyl-5-(4-biphenyl-4-cyclopropanecarboxylic acid)-3-methylisoxazole-4-yl carbamate sodium salt

Treatment of idiopathic pulmonary fibrosis

Bristol-Myers Squibb Company



45

n/a 7/12/200746

n/a 12/19/2007 AbbVie, Inc47

n/a 7/3/2003 Phase 2 Discovery, Inc.

(R)-2-methyl-6-nitro-2-{4-[4-(4-trifluoromethoxyphenoxy)piperidin-1-yl]phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole

Treatment of pulmonary tuberculosis.

Otsuka Pharmaceutical Company, Ltd

(R)-4-(3-morpholin-4-yl-1-phenylsulfanylmethyl-propylamino)-N-(4-{4-[2-(4-chlorophenyl)-5,5-dimethylcyclohex-1-enylmethyl]-piperazin-1-yl}-benzoyl)-3-trifluoromethanesulfonylbenzenesulfonamide bis-hydrochloride

Treatment of small cell lung cancer.

(R)-N-[2-(6-Chloro-methoxy-1H-indol-3yl)propyl]acetamide

Treatment of neuroleptic-induced tardive dyskinesia in schizophrenia patients



48

n/a 10/3/2001 Phase 2 Discovery, Inc.49

n/a 3/17/2014 Pharnext SAS50

n/a 11/5/2014 BerGenBio AS51

Lipotecan 10/6/2010

(R)-N-[2-(6-chloro-5-methoxy-1H-indol-3-yl)propyl]acetamide

Treatment of circadian rhythm sleep disorders in blind people with no light perception

(RS)-baclofen, naltrexone and D-sorbitol

Treatment of Charcot-Marie-Tooth disease type 1A

(S)-1-(6,7-Dihydro-5H-benzo[6,7]cyclohepta[1,2-c]pyridazin-3-yl)-N3-(7-(pyrrolidin-1-yl)-6,7,8,9-tetrahydro-5H-benzo[7]annulen-2-yl)-1H-1,2,4-triazole-3,5-diamine

Treatment of acute myeloid leukemia

(S)-10-[(dimethylamino)methyl]-4-ethyl-9hydroxy-4-O-[a-(2",4",5",7"-tetranitro-9"-fluorenylideneaminooxy)propionyl]- 1H-pyrano[3',4',6',7',] indolizino [1,2-B]-quinoline-3, 14-(4H, 12H)-dione, hydrochloride

Treatment of hepatocellular carcinoma

TLC Biopharmaceuticals, Inc.



52

n/a 1/26/2015 Almirall S.A.53

n/a 11/17/2014 Pulmokine, Inc.54

n/a 8/1/201355

n/a 2/4/2009 Ferrokin BioSciences, Inc.

(S)-2-(1-((6-amino-5-cyanopyrimidin-4-yl)amino)ethyl)-4-oxo-3-phenyl-3,4-dihydropyrrolo[2,1-f][1,2,4]triazine-5-carbonitrile

Treatment of pemphigus vulgaris

(S)-3-((3-(1-((6-((3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium

Treatment of pulmonary arterial hypertension

(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one

Treatment of follicular lymphoma

Infinity Pharmaceuticals, Inc.

(S)-4,5-dihydro-2[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiaxolecarboxylic acid

Treatment of chronic iron overload in patients with transfusion-dependent anemias



56

n/a 6/24/201357

n/a 10/22/2015 Acerta Pharma BV58

n/a 9/21/2015 Acerta Pharma BV59

n/a 11/17/2014 Khondrion BV

(S)-4-(5-chloro-2-(isopropylamino)pyridin-4-yl)-N-(1-(3-chlorophenyl)-2-hydroxyethyl)-1H-pyrrole-2-carboxamide hydrochloride

Treatment of Stage IIb through Stage IV BRAF mutant melanoma

BioMed Valley Discoveries, Inc.

(S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)-imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)-benzamide

Treatment of Waldenstrom macroglobulinemia.

(S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)-imidazo[1,5-a]pyrazine-1-yl)-N-(pyridine-2-yl)-benzamide

Treatment of mantle cell lymphoma.

(S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride

Treatment of inherited mitochondrial respiratory chain diseases



60

n/a 4/29/2015 Incyte Corporation

n/a 10/6/2015

n/a 8/31/2015 Loxo Oncology, Inc.

n/a 11/12/2014 NeOnc Technologies, Inc.

n/a 3/28/2006 Auris Medical, Inc.

(S)-7-(1-(9H-purin-6-ylamino)ethyl)-6-(3-fluorophenyl)-3-methyl-5H-thiazolo[3,2-a]pyrimidin-5-one

Treatment of Hodgkin lymphoma

(S)-8-{2-Amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester

Treatment of pulmonary arterial hypertension (PAH).

KAROS Pharmaceuticals, Inc.

(S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate

Treatment of soft tissue sarcoma.

(S)-perillyl alcohol temozolomide

Treatment of glioma

(UDU-stereoisomer of c-UJUun UNU-terminal UkUnhibitor)

Treatment of acute sensorineural hearing loss



n/a 5/14/2014

n/a 3/19/2015

n/a 12/3/2014 Cellectar Biosciences, Inc.

n/a 11/19/2012 Teva Pharmaceuticals

n/a 1/31/2012

n/a 5/12/1998 Oxford GlycoSciences

(Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N-(pyrazin-2-yl)acrylohydrazide

Treatment of diffuse large B-cell lymphoma

Karyopharm Therapeutics, Inc.

(monomethoxypolyethylene glycol) recombinant adenosine deaminase

Treatment of adenosine deaminase deficiency in patients with severe combined immunodeficiency

Sigma-Tau Pharmaceuticals, Inc.

1 8-(p[131I]-iodophenyl)octadecyl phosphocholine


1'-{[5-(trifluoromethyl)-2-furyl]methyl}spiro[furo[2,3-f][1,3]benzodioxole-7,3'-indol]-2'(1'H)-one

Treatment of erythromelalgia

1,2:5,6-Dianhdrogalactitol, NSC-132313

Treatment of malignant gliomas

DelMar Pharmaceuticals (BC), Ltd.

1,5-(Butylimino)-1,5 dideoxy,D-glucitol

Treatment of Fabry's disease.



Sapacitabine 6/24/2010 Cyclacel Limited

Sapacitabine 6/24/2010 Cyclacel Limited

n/a 9/1/2011 Eisai, Inc.

n/a 7/8/2015 Cleave Biosciences, Inc.

n/a 3/31/2015 Inventiva Pharma

1-(2-C-cyano-2-deoxy-B-D-arabino-pentafuranosyl)-N4-palmitoylcytosine

Treatment of acute myelogenous leukemia

1-(2-C-cyano-2-deoxy-B-D-arabino-pentafuranosyl)-N4-palmitoylcytosine

Treatment of myelodysplastic syndrome

1-(3-chloro-5-{[4-(4-chloro-2-thienyl)-5-(4-cyclohexylpiperazin-l-yl)-1,3-thiazol-2-yl]carbamoyl}- 2-pyridyl) piperidine-4-caboxylic acid Monomaleate

Treatment of idiopathic thrombocytopenic purpura

1-(4-(benzylamino)-7,8-dihydro-5H-pyrano[4,3-d]pyrimidin-2-yl)-2-methyl-1H-indole-4-carboxamide


1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid




n/a 11/12/2009 Astex Therapeutics Ltd

n/a 1/9/2012 ViroDefense, Inc.

n/a 1/23/2013

Somatother 6/10/1999

n/a 6/7/2011 Oncos Therapeutics

1-Cyclopropyl-3-[3-(5-morpholin-4-ylmethyl-1H-benzoimidazol-2-yl)-1H-pyrazol-4-yl]-urea


1-[(2-Chloro-4-methoxyphenoxy)methyl]-4-[(2,6-dichlorophenoxy) methyl]benzene

Treatment of poliovirus infection.

10 synthetic peptides targeting 5 tumor asociated antigens

Treatment of non-small cell lung cancer in patients expressing HLA-A2

Orphan Synergy Europe Pharma (OSE Pharma)

111Indium pentetreotide

Treatment of somatostatin receptor positive neuroendocrine tumors.

Louisiana State University Medical Center Foundation

12-A-p21 RAS(5-21). 12-C-p21 RAS(5-21). 12-D-p21 RAS(5-21). 12-Rp21 RAS(5-21). 12-S-p21 RAS(5-21). 12-V-p21 RAS(5-21). 13-D-p21 RAS(5-21)




n/a 1/29/2010

n/a 6/1/2015 Lipocine, Inc.

n/a 9/3/2004

n/a 4/16/2015 SolaranRx, Inc.

Betalutin 5/14/2014 Nordic Nanovector AS

n/a 4/30/2014 Cellectar Biosciences, Inc.

n/a 1/26/2015

17 amino acid peptide

Prevention of ischemia reperfusion injury in the lung during lung tranplantation

Apeptico Forschung und Entwicklung GmbH

17-a-hydroxyprogesterone caporate (oral formulation)

Prevention of preterm birth in women with a singleton pregnancy

17-allylamino-17-demethoxygeldanamycin (17-AGG)

Treatment of chronic myelogenous leukemia


177-LU-DOTA-GlyGlyNle-CycMSHhex

Treatment of Stage IIB through IV malignant melanoma

177Lu-tetraxetan-tetulomab

Treatment of Follicular Lymphoma

18-(p-[124I]-iodophenyl)octadecyl phosphocholine

Diagnostic for the management of glioma

18Fluorine-N-3-Fluoropropyl-2beta-carbomethoxy-3beta-(4-iodophenyl) Nortropane

Diagnostic to be used in the management of multiple system atrophy (MSA)

Advanced Imaging Projects, LLC



n/a 6/18/2008

n/a 10/31/2012 LifeSplice Pharma LLC

2'-deoxycytidine n/a 9/9/1996 Grant, Steven M.D.

n/a 3/9/2012

n/a 1/15/2015

n/a 9/10/2015 InFlectis BioScience

2 dimethylbutyrate

Treatment of beta thalassemia

HemaQuest Pharmaceuticals, Inc.

2'-O-methyl phosphorothioate 5'-GCUAGGUUUACGGGACCUCU-3'

Treatment of amyotrophic lateral sclerosis

As a host-protective agent in the treatment of acute myelogenous leukemia.

2,2'-{2-[1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid (ixazomib citrate)

Treatment of systemic light chain (AL) amyloidosis.

Millennium Pharmaceuticals, Inc.

2,5-dimethyl-3-[2-methyl-4-(methyloxy)phenyl]-N-[(1S)-1-(3-methyl-1,2,4-oxadiazol-5-

Treatment of congenital adrenal hyperplasia (CAH)

Neurocrine Biosciences, Inc.

2-(2-chlorobenzylidene)hydrazinecarboximidamide acetate

Treatment of Charcot-Marie Tooth disease.



n/a 9/21/2010 GenKyoTex S.A.

n/a 1/29/2010 EntreMed, Inc.

n/a 7/1/2014


2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione

Treatment of idiopathic pulmonary fibrosis.

2-(2-phenylvinyl)-4-[-methylpiperazin-l-yl)]-6-(5-methyl-2H-pyrazol-3-yl-amino)-pyrimidine L(+) tartrate salt

Treatment of acute myeloid leukemia.

2-(2-phenylvinyl)-4-[4-methylpiperazin-1-yl)]-6-(5-methyl-2H-pyrazol-3-yl-amino)-pyrimidine L(+) tartrate salt


CASI Pharmaceuticals, Inc.

2-(2-phenylvinyl)-4-[4-methylpiperazin-l-yl)]-6-(5-methyl-2H-pyrazol-3-yl-amino)-pyrimidine L(+) tartrate salt

Treatment of multiple myeloma.




n/a 1/26/2015 Incyte Corporation

Atiprimod 9/18/2006

Atiprimod 12/2/2003

2-(2-phenylvinyl)-4-[4-methylpiperazin-l-yl)]-6-(5-methyl-2H-pyrazol-3-ylamino)-pyrimidine L(+) tartrate salt

Treatment of ovarian carcinoma

2-(3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-l-yl)-1-(1-(3-fluoro-2-(trifluoromethyl)isonicotinoyl)piperidin-4-yl)azetidin-3-yl)acetonitrile adipate


2-(3-Diethylaminopropyl)-8,8-dipropyl-2-azaspiro[4,5] decane dimaleate

Treatment of carcinoid tumors

Callisto Pharmaceuticals, Inc.

2-(3-diethylaminopropyl)-8,8-dipropyl-2-azaspiro [4,5] decan dimaleate

Treatment of mulitple myeloma and associated bone resorption




n/a 6/1/2015 Aptose Biosciences, Inc.

n/a 5/13/2015 Flatley Discovery Lab

n/a 8/15/2003 Inologic, Inc.

Aeropin 9/17/1993 Kennedy & Hoidal, M.D.'s

n/a 2/17/2012 Can-Fite BioPharma Ltd.

2-(5-fluoro-2-methyl-1H-indol-3-yl)-1H-imidazo[4,5-f][1,10] phenanthroline


2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl)acetamide


2-0-Butyryl-1-0-octyl-myo-inositol 3,4,5,6-tetrakisphosphate


2-0-desulfated heparin


2-Chloro-N6--(3-iodobenzyl)adenosine-5'-N-methyluronamide




n/a 9/18/2015 Gilead Sciences, Inc.

n/a 4/9/2015 Eli Lilly and Company

Prevonco (Tm) 8/27/2008 BioQuant, Inc.

2-Ethylbutyl (2S)-2-{[(S)-{[(2R,3S,4R,5R)-5-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate

Treatment of Ebola virus disease

2-Pyrazinecarbonitrile, 5-[[5-2-(3-aminopropoxy)-6-methoxyphenyl]-1H-pyrazol-3-yl]amino] monomesylate monohydrate

Treatment of anal cancer

2-[(3-methyl-4-(2,2,2-trifluoroethoxy) pyridin-2-yl)methylsulfinyl] -1H-benzoimidazole

Treatment of hepatocellular carcinoma.



n/a 9/29/2015 Tensha Therapeutics, Inc.

n/a 7/16/2014 OncoEthix SA

n/a 12/18/2007 AbbVie, Inc.

n/a 6/2/2014 Pfizer Inc.

n/a 5/14/2013 Sanofi U. S., Inc.

2-[(4S)-6-(4-chlorophenyl)-1,7,8-trimethylthiophenol[3,2-f]1,2,4-triazolo[4,3-a]1,4-diazepin-4-yl]-N-[3-(4-methylpiperazinyl)propyl]acetamide

Treatment of nuclear protein in testis (NUT) midline carcinoma.

2-[(6S)-4-(4-chlorophenyl)-2,3,9-trimethyl-6H-thienol[3,2,-f]-[1,2,4]triazolo[4,3-a][1,4]diazepin-6-yl]-N-(4-hydroxyphenyl)-acetamide dihydrate


2-[(R)-2-methylpyrrolidin-2-yl]-1H-benzimadazole-4-carboxamide

Treatment of malignant melanoma stages IIb through IV.

2-[4-(1-Methyl-4-pyridin-4-yl-lH-pyrazol-3-yl)-phenoxymethyl]-quinoline succinic acid

Treatment of Huntington's disease.

2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indian-2-carboxylic acid

Treatment of patients with systemic sclerosis



n/a 4/15/2015

n/a 3/18/2015

n/a 1/19/2010

n/a 10/6/2015

Sarmustine 11/15/2001 Pangene Corporation

2-[4-[[(2-R)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]thio]-2-methylphenoxy]acetic acid (1:1) lysine dihydrate

Treatment of patients with Frederickson Type I or V hyperlipoproteinemia

CymaBay Therapeutics, Inc.

2-[4-[[(2R)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]thio]-2-methylphenoxy]acetic acid (1:1) lysine dihydrate

Treatment of homozygous familial hypercholesterolemia (HoFH)

CymaBay Therapeutics, Inc.

2-[[3-({4-[(5-{2-[(3-Fluorophenyl)amino]-2-oxoethyl}-1H-pyrazol-3-yl)amino]-quinazolin-7-yl}propyl](ethyl)amino]ethyl dihydrogen phosphate trihydrate


AstraZeneca Pharmaceuticals LP

2-amino-2-[2-[2-chloro-4-[[3-(phenylmethoxy) phenyl] thio]phenyl]ethyl]1,3-propanediol hydrochloride

Prevention of graft versus host disease.

Novartis Pharmaceuticals Corporation

2-chloroethyl-3-sarcosinamide-1-nitrosourea

Treatment for malignant glioma



n/a 8/3/2001 Lawrence Panasci, MD

Kleptose 2/18/2013 Vtesse, Inc.

2-iminobiotin n/a 2/24/2009 Neurophyxia B.V.

Pulmolar 4/11/2005 PR Pharmaceuticals, Inc.

n/a 6/23/2015 Rgenix, Inc.



2-chloroethyl-3-sarcosinamide-1-nitrosourea

Treatment for malignant gliomas

2-hydroxypropyl-B-cyclodextrin

Treatment of Niemann Pick disease, type C.

Treatment of perinatal asphyxia.

2-methoxyestradiol


2-{3-[(3R)-3-({[2-chloro-3-(trifluoromethyl)phenyl]methyl}(2,2-diphenylethyl)amino)butoxy]phenyl}acetic acid

Treatment of malignant melanoma stages IIB to IV.


Treatment of ovarian cancer.


Treatment of glioblastoma multiforme.



n/a 8/28/2014

n/a 12/10/2004 Rexahn Corporation





n/a 11/25/2014

n/a 2/27/1987 Lemmon Company

2-{[(1r,4r)-4-(((4-chlorophenyl)(phenyl)carbamoyloxy)methyl)cyclohexy]methoxy} acetic acid


Arena Pharmaceuticals, Inc.

20-mer complementary to Akt mRNA

Treatment of stomach cancer

20-mer oligonucleotide complementary to Akt mRNA

Treatment of glioblastoma


Treatment of renal cell carcinoma


Treatment of ovarian cancer



225Ac-lintuzumab


Actinium Pharmaceuticals, Inc.

24,25 dihydroxycholecalciferol

Treatment of uremic osteodystrophy.



n/a 3/9/2012

n/a 4/30/2010 MS Therapeutics Limited

n/a 12/18/1990

n/a 9/20/2000 Elliot Danforth, Jr., M.D.

n/a 5/14/2013

n/a 3/23/2000 Sugen, Inc.


2S,4R ketoconazole

Treatment of endogenous Cushing's syndrome

Cortendo AB (HQ address)

3,4 diaminopyridine and choline bitartrate

Treatment of Lambert-Eaton myasthenic syndrome

3,4-diaminopyridine

Treatment of Lambert-Eaton myasthenic syndrome.

Jacobus Pharmaceutical Company

3,5,3'-triiodothyroacetate

Treatment of well-differentiated papillary, follicular or combined papillary/follicular carcinomas of the thyroid gland.

3,5-diiodothyropropionic acid

Treatment of Allan-Herndon-Dudley syndrome

Zarion Pharmaceuticals P/L

3-(3,5-Dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-2-one

Treatment of von Hippel-Lindau disease.

3-(3,5-dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-2-one

Treatment of Kaposi's sarcoma.



n/a 7/14/2015

n/a 7/14/2015

n/a 3/2/2010

n/a 12/23/2014

3-bromopyruvate n/a 4/29/2014 PreScience Labs, LLC

3-(4-(1,5-Napthrydine)-Imidazole[1,2-a]pyridine-7-(1-phenyl-4-(1-(4-methyl piperazine)

Treatment of fibrodysplasia ossificans progressiva.

La Jolla Pharmaceutical Company, Inc.

3-(4-(8-fluoroquinoline)-Imidazole[1,2-a]pyridine-7-(1-phenyl-4-(1-(4-methyl piperazine)

Treatment of fibrodysplasia ossificans progressiva.


3-(6-(1-(2,2-difluorobenzo[d] [1,3]dioxyl-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid



3-[2-(4-carbamimidoyl-phenylcarbamoyl)-5-methoxy-4-vinyl-phenyl]-6-(cyclopropylmethyl-carbamoyl)-pyridine-2-carboxylic acid

Prevention of acute attacks of angioedema in individuals with hereditary angioedema

BioCryst Pharmaceuticals, Inc.




3-bromopyruvate n/a 3/5/2013 Primocure Pharma, Inc.

n/a 10/25/2013 Neurolixis, Inc.

n/a 7/28/2008 Seaside Therapeutics

n/a 2/11/2015

n/a 11/9/2015 ArQule, Inc.

10/30/2008

Treatment of liver and intrahepatic bile duct cancer

3-chloro-4-fluorophenyl-[4-fluoro-4-[[(5-methylpyrimidin-2-ylmethyl)amino]methyl]piperidin-1yl]methanone

Treatment of Rett syndrome

3-fluoro-5-[5-(2-menthyl-thiazol-4-ylethylnyl)-pyridin-2-yl]-benzonitrile dihydrochloride

Treatment of behavioral abnormalities associated with fragile X syndrome.

3-pentylbenzenacetic acid sodium salt


ProMetic Life Sciences, Inc.

3-{3-[4-(1-aminocyclobutyl)phenyl]-5-phenyl-3H-imidazo[4,5-b]pyridin-2-yl}cpyridin-2-amine bis-mesylate

Treatment of Proteus Syndrome.

4, 5 dibromorhodamine methyl ester

Theralux Photodynamic Therapy


Kiadis Pharma Canada, Inc.



10/30/2008

10/23/2007

n/a 4/18/2011

n/a 10/11/2006

n/a 12/12/2005

4, 5 dibromorhodamine methyl ester




4,5 dibromorhodamine methyl ester


For immune reconstitution and prevention of graft versus host disease following allogeneic hematopoietic stem cell transplantation.

Kiadis Pharma Netherlands B.V.

4,5,6,7-tetrachloro-2',4',5',7'-tetraiodofluorescein disodium salt


Provectus Pharmaceuticals, Inc.

4-(2-fluorophenyl)-6-methyl-2-(1-piperzinyl)

Treatment of Chronic Functional Vomiting to include functional vomiting and cyclic vomiting syndrome.

Dynogen Pharmaceuticals, Inc.

4-(3-Methanesulfonyl-phenyl)-1-propylpiperidine HCl


Teva Branded Pharmaceutical Products R&D



n/a 3/24/2015 Clanotech AB

n/a 3/27/2014 AbbVie

n/a 9/20/2012 AbbVie, Inc

4-(4-Methoxy-phenylamino)-6-methylcarbamyl-quinoline-3-carboxylic acid

Prevention of scarring post ab externo glaucoma surgery

4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide

Treatment of diffuse large B-cell lymphoma.

4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide

Treatment of chronic lymphocytic leukemia



n/a 4/15/2013


n/a 8/22/2007

4-Aminopyridine n/a 12/14/2005 Acorda Therapeutics, Inc.

n/a 9/29/2015

4-(6-(4-(piperazin-1-yl)phenyl_pyrazolo[1,5-a]pyrimidin-3-yl)quinoline hydrochloride

Treatment of fibrodysplasia ossificans progressiva


4-(pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one

Treatment of congenital long QT syndrome

4-Amino-1-[5-O-[(2R, 4S)-2-oxido-4-(4-pyridinyl)-1, 3, 2-dioxaphosphorinan-2-yl]-b-D-arabinofuranosyl]-2(1H)-pyrimidinone


Ligand Pharmaceuticals, Inc.

Treatment chronic functional motor and sensory deficits from Guillain-Barre syndrome

4-Hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl

Treatment of cerebral cavernous malformation.

REcursion Pharmaceuticals, LLC



n/a 11/18/2015 ARMGO Pharma, Inc.

n/a 1/4/2011 Therapeia GmbH & Co KG

n/a 7/30/2008 SuperGen, Inc.

n/a 10/4/2011

n/a 9/3/2009

4-[(7-Methoxy-2,3-dihydro-1,4-benzothiazepin-4(5H)-yl)methyl]benzoic acid, hemifumarate

Treatment of patients with Duchenne Muscular Dystrophy.

4-[131I]iodo-L-phenylalanine

Treatment of glioma.

4-[1]benzofuro[3,2-d]pyrimidin-4-yl-N-(1,3-benzodioxol-5-ylmethyl)piperazine-1-carbothioamide

Treatment, in combination with radiotherapy and temozolomide chemotherapy, of patients with glioblastoma multiforme.

4-[2-(3-Propyl-[1,2,4]0xadiazol-5-yl)-vinyl]-benzene-1,2-diol

Treatment of chronic myeloid leukemia

Piramal Enterprises Limited

4-[4-[[[[3-(1,1-dimethylethyl)-1-(6-quinolinyl)-1H-pyrazol-5-yl]amino]carbonyl]-amino]-3-fluorophenoxyl]-N-methyl-2-pyridinecarboxamide, p-toluenesulfonate salt

Treatment of Philadelphia chromosome positive chronic myeloid leukemia

Deciphera Pharmaceuticals, LLC



n/a 9/23/2011 Celgene Corporation

n/a 9/23/2014

12/13/1989 Beeken, Warren M.D.

Paser Granules 4/26/2006

4-[[9-(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-trifluorophenyl)amino]-9H-purin-2-yl]amino]-trans-cyclohexanol


4-amino-1-[(1S,4R,5S)-2-fluoro-4,5-dihydroxy-3-(hydroxymethyl) cyclopent-2-en-1-yl] pyrimidin-2-one

Treatment of pancreatic cancer.

Rexahn Pharmaceuticals, Inc.

4-aminosalicylic acid

Pamisyl (P-D), Rezipas (Squibb)

Treatment of mild to moderate ulcerative colitis in patients intolerant to sulfasalazine.

4-aminosalicylic acid

Treatment of acute flares in pediatric patients with ileo-cecal Crohn's disease

Jacobus Pharmaceutical Co., Inc.



n/a 7/20/2006

n/a 11/2/2010

n/a 5/19/2014 Roche Genentech

n/a 3/18/2013 Novo Nordisk, Inc.

4-cyano-N-[2-(1-cyclohexen-1-yl)-4-[1-[dimethylamino)acetyl]-4-piperidinyl]phenyl]-1H-imidazole-2-carboxamide monohydrochloride


Johnson & Johnson Pharmaceutical Research & Dev,

4-pyridinylmethyl 3(4-chlorophenyl)adamantine carboxamide


Apogee Biotechnology Corporation

4-{[(2R,3S,4R,5S)-4-(4-Chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid

Treatment of Acute Myeloid Leukemia

40K PEGylated recombinant factor IX

Routine prophylactic administration for prevention of bleeding in patients with hemophilia B (Christmas disease)



n/a 3/31/2015

n/a 10/31/2012

n/a 6/15/2007

n/a 8/20/2003 Now Pharm AG

n/a 5/11/1992 ILEX Oncology, Inc.

n/a 9/4/2014

n/a 6/18/2007 Humanetics Corporation

5'-CTATCTGUC*G1TTCTCTGU-3'.17 Na+


Idera Pharmaceuticals, Inc.

5'-GCCATGGTTTTTTCTCAGG-3'

Prophylaxis for patients following documented or suspected exposure to ebolavirus

Sarepta Therapeutics, Inc.

5(S)-(2'-hydroxy ethoxy)-20(S)-Camptothecin

Treatment of osteosarcoma (bone cancer)

Dr. Reddy's Laboratories, Inc.

5,5',5"-[Phosphinothioylidyne-tris(imino-2,1-ethanediyl)]tris[5-methylchelidoninium]trihydroide hexahydrochloride


5,6-dihydro-5-azacytidine

Treatment of malignant mesothelioma.

5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride

Treatment of Huntington's disease

Prana Biotechnology Limited

5,7-dihydroxy-3-(4-hydroxyphenyl)-chromen-4-one

Prevention of acute radiation syndrome



n/a 4/18/2011 Mithridion, Inc.


n/a 11/22/2011 Summit Corporation plc

Resveratrol 3/13/2008

n/a 8/25/2009 Pfizer Incorporated

n/a 2/10/2015 Verastem, Inc.

5-(3-ethyl-1,2,4-oxadiazol-5-yl)-1,4,5,6-tetrahydropyrimidine hydrochloride

Treatment of progressive supranuclear palsy.

5-(4-Cyclopropyl-1H-imidazol-l-yl)-2-fluoro-N-(6-(4-isopropyl-4H-1,2,4-triazol-3-yl)pyridin-2-yl)-4-methylbenzamide

Treatment pulmonary arterial hypertension

5-(ethylsulfonyl)-2-(naphthalen-2-yl)benzp[d]oxazole

Treatment of Duchenne Muscular Dystrophy

5-[(E)-2-(4-hydroxyphenyl)-ethenyl] benzene-1,3 diol

Treatment of MELAS syndrome

Sirtris Pharmaceuticals, Inc.

5-[1-(2,6-Dichlorobenzyl)-piperidin-4-yl]methoxyquinazoline-2,4-diamine

Treatment of spinal muscular atrophy

5-[8-methyl-9-(1-methylethyl)-2-(4-morpholinyl)-9H-purin-6yl]-2-pyrimidinamine

Treatment of malignant mesothelioma



Gliolan 1/15/2013


n/a 5/26/2006 Baxalta US, Inc.

n/a 5/26/2006 Hana Biosciences, Inc.

n/a 10/31/2012

n/a 2/6/2006

n/a 9/26/2013

n/a 8/22/2011

5-aminolevulinic acid

Visualization of malignant tissue during surgery for malignant glioma (WHO garde III and IV)

NX Development Corporation

5-aza-2'-deoxycytidine

Treatment of acute leukemia.

5-hydroxymethyl-2-furfuraldehyde

Treatment of sickle cell disease

5-iodo-2-pytimidinone-2'-deoxyribose

Treatment of malginant glioma

5Ã¿Â¿Ã¿Ã¿Ã¿Â¢Ã¿Â¿Ã¿Ã¿Â¬"-GAATATTAACAIACTGACAAGTC-3Ã¿Â¿Ã¿Ã¿Ã¿Â¢Ã¿Â¿Ã¿Ã¿Â¬"

Prophylaxis following documented or suspected exposure to marburg virus


6,8-bis-benzylsulfanyl-octanoic acid


Cornerstone Pharmaceuticals, Inc.









n/a 9/4/2014 Pfizer, Inc.


n/a 6/12/2014 DARA BioSciences, Inc.

n/a 4/9/2008

6-((3S,4S)-4-Methyl-1-pyrimidin-2-ylmethyl-pyrrolidin-3-yl-1-(tetrahydro-pyran-4-yl)-1,5-dihydro-pryazolo[3,4-d]pyrimidin-4-one


6-(1H-Indazol-6-yl)-N-(4-morpholinophenyl)imidazo-[1,2-alpha]pyrazin-8-amine bis-methanesulfonate


6-[4-Deoxy-4-[(2E,4E)-tetradecadienoylglycyl]amino-L-glycero-B-L-manno-heptopyranosyl]amino-9H-purine


6-alpha-ethylchenodeoxycholic acid


Intercept Pharmaceuticals, Inc.



n/a 10/15/2013

n/a 6/18/2015 Sixera Pharma AB

n/a 12/7/2009 Orbona Pharma Ltd

n/a 9/24/2014

n/a 6/15/2011 Intsel Chimos SA

n/a 1/21/2015 RestorGenex Corporation

6-amino-5-chloro-N-[1R)-1-[5-[[[5-hloro-4-(trifluoromethyl)-2pyridinyl]amino]carbonyl]-2-thiazoyl]ethyl]-4-pyrimdinecarboxamide

Treatment of stage IIb-IV melanoma


6-ethoxy-7-methoxy-2-(2-methylsulfanylphenyl)-3,1-bensoxazin-4-one

Treatment of Netherton syndrome

6-mercaptopurine oral liquid

Treatment of acute lymphoblastic leukemia in the pediatric population

68G-OPS202, small somatostatin analog labeled with 68Gallium

Management of gastroenteropancreatic neuroendocrine tumors.

OctreoPharm Sciences GmbH

7-B-Hydroxy Cholesteryl-3-B-Oleate-Ester

Treatment of gliomas.

8-(1-Hydroxy-ethyl)-2-methoxy-3-(4-methoxy-benzyloxy)-benzo[c]chromen-6-one

Treatment of glioblastoma multiforme



n/a 9/3/2009

8-methoxsalen Uvadex 6/22/1993 Therakos, Inc.

Camvirex 5/15/2001


90Y-hPAMA4 Pan-Cide 1/29/2004 Immunomedics, Inc.

Resimmune 10/9/2014 Angimmune, LLC

n/a 9/3/2004

n/a 3/11/2013

8-[4-(1-aminocyclobutyl)phenyl]-9-phenyl-1,2,4-triazolo[3,4-f][1,6]naph-thyrin-3(2H)-one mono-hydrochloride


Merck Sharp & Dohme Corp.

For use in conjunction with the UVAR photopheresis to treat diffuse systemic sclerosis.

9-nitro-20-(S)-camptothecin

Treatment of pediatric HIV infection/AIDS

NovoMed Pharmaceuticals, Inc.

9-nitro-20-(S)-camptothecin



A-dmDT390-bisFv(UCHT1)

Treatment of cutaneous T-cell lymphoma

A10 & AS2-1 Antineoplaston

Treatment for patients with brain stem glioma

Burzynski Research Institute, Inc.

AAV-G6Pase vector

Treatment of glycogen storage disease type Ia

GlyGenix Therapeutics, Inc.



n/a 10/28/2015

n/a 9/28/2012

ADXS11-001 n/a 8/12/2013 Advaxis, Inc.

n/a 4/30/2010 Aeterna Zentaris

n/a 4/14/2009 Ablynx NV

n/a 7/7/2015

n/a 9/12/2008

Abetimus n/a 7/28/2000

ABCA4 DNA nanoparticles

Treatment of Stargardt Macular Degeneration

Copernicus Therapeutics, Inc.

ADF-APO-CCN-GUC-K67-MET-MMP-MUC-RGS; HLA class I/II binding tumor associated peptides

Treatment of renal cell carcinoma in HLA-A*2 positive patients

Immatics Biotechnologies GmbH

Treatment of HPV-positive associated anal cancer

AEZS-108 (LHRH-agonist linked to doxorubicin)


ALX-0081 nanobody, directed towards the human A1 domain of von Willebrand factor

Treatment of thrombotic thrombocytopenic purpura

ANA-conjugated dactunomycin nanoemulsion

Treatment of Ewing sarcoma

NanoSmart Pharmaceuticals, Inc.

AQ-13 (4-aminoquinoline analog)

Treatment of malaria

Immtech Pharmaceuticals, Inc.

Treatment of lupus nephritis.

La Jolla Pharmaceutical Co.



n/a 4/20/2014

Acetylcysteine 8/13/1987

ActRIIB-IgG1) n/a 8/16/2010 Acceleron Pharma, Inc.


n/a 1/31/2012 ReGenX Biosciences LLC

Ac-Ile-Cys-Val-Trp(1-Me)-Gln-Asp-Trp-Gly-Ala-His-Arg-Cys-Thr-AEEA-Lys-PEG 40KDa-Lys-AEEA-Thr-Cys-Arg-His-ALa-Gly-Trp-Asp-Gln-(1-Me)Trp-Val-Cys-Ile-Ac

Treatment of paroxysmal nocturnal hemoglobinuria

Apellis Pharmaceuticals, Inc.

Mucomyst/Mucomyst 10 Iv

Intravenous treatment of patients presenting with moderate to severe acetaminophen overdose.


Treatment of Duchenne muscular dystrophy

Ad5/3-D24-granulocyte-macrophage colony stimulating factor (GMCSF)-encoding oncolytic adenovirus


Adeno-Associated Viral Vector Expressing Low-Density Lipoprotein Receptor

Treatment of homozygous familial hypercholesterolemia



n/a 5/21/2007 uniQure B.V.

Coagulin-B 6/13/2001 Avigen, Inc.

Coagulin-B 6/13/2001 Avigen, Inc.

n/a 3/20/2007

n/a 8/25/2015 Dimension Therapeutics

Adeno-associated vector expressing the human lipoprotein lipase protein

Treatment of lipoprotein lipase deficiency

Adeno-associated viral vector containing the gene for human coagulation factor IX

Intrahepatic treatment of patients with moderate to severe hemophilia

Adeno-associated viral vector containing the gene for human coagulation factor IX

Intramuscular treatment of patients with moderate to severe hemophilia

Adeno-associated viral vector expressing human acid alpha glucosidase gene

Treatment of Pompe disease

Applied Genetic Technologies Corporation

Adeno-associated virus serotype rh10 vector encoding the human factor IX gene

Treatment of hemophilia B.



n/a 9/4/2014


n/a 6/17/2005 Advantagene, Inc.

n/a 7/23/2015 Ziopharm Oncology, Inc.

Adenoassociated virus vector (AAV) carrying a modified AAV serotype 2 backbone and coding sequence of human thymidine phosphorylase preceded by a human thyroxin-binding globulin promoter

For the treatment of Mitochondrial Neurogastrointestinal Encephalomyopathy (MNGIE)

Columbia University Medical Center

Adenosine triphosphate type 1 competitive inhibitor of JAK2 V617F tyrosine kinase

Treatment of myeloproliferative disorders (polycythemia vera, essential throbocythemia, and myelofibrosis)

Adenoviral vector expressing Herpes simplex virus thymidine kinase gene

Treatment of malignant brain tumors

Adenoviral vector-RheoSwitch Therapeutic System-human interleukin 12 + veledimex

Treatment of malignant glioma.



n/a 9/4/2014 Etubics Corporation

Miniadfviii 12/15/1999

Albendazole Albenza 1/17/1996

Adenovirus serotype-5 (Ad5) vector that contains a modified non-oncogenic fused early 6 (E6) and early 7 (E7) gene of the human papillomavirus (HPV); (Ad5 [E1-, E2b-]-E6/E7)

Treatment of human papillomavirus (HPV)-associated head and neck squamous cell carcinoma (HNSCC)

Adenovirus-based vector Factor VIII complementary DNA to somatic cells

Treatment of hemophilia A.

GenStar Therapeutics Corporation

Treatment of hydatid disease (cystic echinococcosis due to E. granulosus larvae or alveolar echinococcosis due to E. multilocularis larvae).

Amedra Pharmaceuticals LLC



Albendazole Albenza 1/18/1996

Albuterol n/a 3/12/2002 MotoGen, Inc.

Aldesleukin Proleukin 11/24/1998

Aldesleukin Proleukin 3/22/1989

Treatment of neurocysticercosis due to Taenia solium as: 1) chemotherapy of parenchymal, subarachnoidal and racemose (cysts in spinal fluid) neurocysticercosis in symptomatic cases and 2) prophylaxis of epilepsy and other sequelae in asymptomatic neurocysticercosis.

Amedra Pharmaceuticals LLC

Prevention of paralysis due to spinal cord injury

For the treatment non-Hodgkin's lymphoma.

Prometheus Laboratories, Inc.

Treatment of primary immunodeficiency disease associated with T-cell defects.

Prometheus Laboratories, Inc.



Aldesleukin Proleukin 9/14/1988 Chiron Corporation

Aldesleukin Proleukin 9/10/1996 Chiron Corporation

Fosamax 2/13/2001

Alfentanil n/a 7/8/2005 Cinergen, LLC

Alfentanil n/a 8/9/2005 Cinergen, LLC

Ceredase 3/11/1985 Genzyme Corporation

Ceredase 7/21/1995 Genzyme Corporation

Alitretinoin Panretin 4/10/1992

Alitretinoin Panretin 3/24/1998 Eisai, Inc

Treatment of metastatic renal cell carcinoma.

Treatment of metastatic melanoma.

Alendronate disodium

Treatment of the bone manifestations of Gaucher disease

Richard J. Wenstrup, M.D.

Management of postherpetic neuralgia

Treatment of painful HIV-associated neuropathy

Alglucerase injection

For replacement therapy in patients with Gaucher's disease type I.

Alglucerase injection

Replacement therapy in patients with Type II and III Gaucher's disease.

Treatment of acute promyelocytic leukemia

Ligand Pharmaceuticals, Inc.

Treatment of AIDS-related Kaposi's sarcoma.



n/a 1/28/2005 MolMed S.p.A.

Vascugel (R) 4/3/2009 Shire

Allogeneic T-cells cultured with anti-CD3 and IL-2; transduced with retroviral vector (SFCMM-3), expressing herpes simplex 1 virus-thymidine kinase (HSV-TK) and truncated low affinity nerve growth factor receptor; selected with anti-low affinity nerve gro

Immunotherapy for acceleration of T-cell reconstitution in patients undergoing allogeneic hematopoietic stem cell transplantation

Allogeneic human aortic endothelial cells cultured in a porcine gelatin matrix

Prevention of arteriovenous fistula or arteriovenous graft failure in patients with end satge renal disease receiving hemodialysis or preparing for hemodialysis



1/17/2014 California Stem Cell Inc.

Cytoimplant 6/13/1997

n/a 9/1/2004 Neurotech USA, Inc.

Allogeneic motor neuron progenitor cells derived from human embryonic stem cells

Motorgraft (Tm)

Treatment of Amyotrophic Lateral Sclerosis

Allogeneic peripheral blood mononuclear cells sensitized against patient alloantigens by mixed lymphocyte culture


Applied Immunotherapeutics, LLC

Allogeneic retinal epithelial cells transfected with plasmid vector expressing ciliary neurotrophic growth factor




10/16/1992

Replagal 6/22/1998

Fabrase 7/20/1990 Desnick, Robert J. M.D.

6/17/1991 David Calhoun, Ph.D.

Allopurinol sodium

Aloprim For Injection

Management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.

Catalytica Pharmaceuticals, Inc

Alpha-galactosidase A

Long-term enzyme replacement therapy for the treatment of Fabry disease





Cc-Galactosidase

Treatment of alpha-galactosidase A deficiency (Fabry's disease).



n/a 8/19/1997

n/a 3/28/2006

n/a 12/22/2004 Kamada Ltd.

Arc-Api 9/1/2004 Kamada Ltd.

n/a 4/3/2008 Kamada Ltd.

Prolastin 12/7/1984 Bayer Corporation

Alpha-melanocyte stimulating hormone

Prevention and treatment of intrinsic acute renal failure due to ischemia.

National Institute of Diabetes, and Digestive and Kidney Diseases

Alpha-tocopherol quinone

Treatment of inherited mitochondrial respiratory chain diseases

Penwest Pharmaceuticals Company

Alpha1-Proteinase Inhibitor (Human)

Inhalation therapy for the treatment of congential deficiency of alpha1-proteinase inhibitor.

Alpha1-Proteinase Inhibitor (Human)


Alpha1-antitrypsin(human)

Treatment of bronchiectasis

Alpha1-proteinase inhibitor (human)

For replacement therapy in the alpha-1-proteinase inhibitor congenital deficiency state.



Altretamine Hexalen 2/9/1984

Alvocidib n/a 4/13/2007

Amantadine HCl n/a 7/20/2015

Nurelin 4/9/2015

Amifostine Ethyol 11/24/1998 Clinigen Group plc


Treatment of advanced adenocarcinoma of the ovary.

Medimmune Oncology, Inc.

Teatment of B-cell chronic lymphocytic leukemia (B-CLL) or prolymphocytic leukemia arising from CLL.

Tolero Pharmaceuticals, Inc.

Treatment of levodopa-induced dyskinesia

Osmotica Pharmaceutical Corporation

Amantadine hydrochloride

Treatment of levodopa-induced dyskinesia

Adamas Pharmaceuticals, Inc.

For the reduction of the incidence and severity of toxicities associated with cisplatin administration.

For use as a chemoprotective agent for cyclophosphamide in the treatment of advanced ovarian carcinoma.




Amifostine Ethyol 5/30/1990


Amifostine Ethyol 5/12/1998

Caprogel 1/6/1995

For use as a chemoprotective agent for cisplatin in the treatment of metastatic melanoma.

For use as a chemoprotective agent for cisplatin in the treatment of advanced ovarian carcinoma.


Treatment of myelodysplastic syndromes.

Reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer.


Aminocaproic acid

For the topical treatment of traumatic hyphema of the eye.

Eastern Virginia Medical School



Paser Granules 2/19/1992

Aminosidine Gabbromicina 5/14/1993

Aminosidine Paromomycin 9/9/1994

Aminosidine Gabbromicina 11/15/1993

Amiodarone Amio-Aqueous 8/17/1993

Amiodarone HCl Cordarone 3/16/1994

Coprexa 1/31/1994

Aminosalicylic acid

Treatment of tuberculosis infections


Treatment of tuberculosis.

Kanyok, Thomas P. Pharm.D.

Treatment of visceral leishmaniasis (kala-azar).


Treatment of Mycobacterium avium complex.


Treatment of incessant ventricular tachycardia.

Academic Pharmaceuticals, Inc.

For the acute treatment and prophylaxis of life-threatening ventricular tachycardia or ventricular fibrillation.

Wyeth-Ayerst Laboratories

Ammonium tetrathiomolybdate

Treatment of Wilson's disease.

Pipex Pharmaceuticals, Inc.



n/a 12/15/2005

Abelcet 12/5/1991 Liposome Company, Inc.

12/18/2006 Akorn, Inc.

Anagrelide Agrylin 6/11/1985


Amphotericin B inhalation powder

Prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy including those receiving organ or stem cell transplants, or treated with chemotherapy or radiation for hematologic malignancies


Amphotericin B lipid complex

Treatment of invasive fungal infections.

Amyl nitrite, sodium nitrite, sodium thiosulfate

Cyanide Antidote Kit

Treatment of cyanide poisoning

Treatment of polycythemia vera.

Roberts Pharmaceutical Corp.

Treatment of thrombocytosis in chronic myelogenous leukemia.





Vianain 1/21/1992 Genzyme Corporation

Anatibant n/a 4/15/2005 Xytis, Inc.

Ancrod Viprinex 10/20/1989

Angiotensin (1-7) n/a 11/26/2013 US Biotest, Inc.

Treatment of essential thrombocythemia.


Ananain, comosain

For the enzymatic debridement of severe burns.

Treatment of patients having experienced a severe traumatic brain injury (Glasgow Coma Scale 3 to 8) in order to decrease early mortality and improve long-term functional and neurological outcome

To establish and maintain anticoagulation in heparin-intolerant patients undergoing cardiopulmonary bypass.

Knoll Pharmaceutical Company

Treatment of limb-girdle muscular dystrophy



Angiotensin 1-7 n/a 2/16/2000 Maret Pharmaceuticals

Angiotensin 1-7 Marstem 8/3/2001

Angiotensin-(1-7) n/a 9/13/2011 US Biotest, Inc.

n/a 8/7/2014 OncoSynergy, Inc.

n/a 4/3/2009 Tolera Therapeutics, Inc.

n/a 5/13/2015

Neuradiab 10/4/2005

Treatment of neutropenia associated with autologous bone marrow transplantation.


Maret Pharmaceutical Corporation

Treatment of pulmonary arterial hypertension.

Anti-Beta1 integrin monoclonal antibody


Anti-T cell receptor murine monoclonal antibody

Prophylaxis of acute rejection of solid organ transplantation

Anti-eTau Humanized IgG4 Monoclonal Antibody

Treatment of Progressive Supranuclear Palsy

Britol-Myers Squibb Company

Anti-tenascin 81C6 monoclonal antibody labeled w/ I 131

Treatment of primary malignant brain tumors

Bradmer Pharmaceuticals, Inc.



6/2/1993

n/a 7/29/2014 Genentech, Inc.

Antiepilepsirine n/a 3/23/1989 Children's Hospital

Alphanate 1/5/1996 Grifols Biologicals Inc.

Anti-thymocyte serum

Nashville Rabbit Anti-Thymocyte Serum

Treatment of allograft rejection, including solid organ (kidney, liver, heart, lung, and pancreas) and bone marrow transplantation.

Applied Medical Research

Antibody drug conjugate consisting of a humanized IgG1 anti-NaPi2b monoclonal antibody and monomethyl auristatin E


Treatment of drug resistant generalized tonic-clonic epilepsy in children and adults.

Antihemophilic factor (human)

Treatment of von Willebrand's disease



Kogenate 9/25/1989 Bayer Corporation

2/8/1996

Humate-P 10/16/1992 CSL Behring

Antihemophilic factor (recombinant)

Prophylaxis and treatment of bleeding in individuals with hemophilia A or for prophylaxis when surgery is required in individuals with hemophilia A.

Antihemophilic factor (recombinant)

Refacto, Xyntha

For the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).

Wyeth Pharmaceuticals, Inc.

Antihemophilic factor/von Willebrand factor complex (human), dried, pasteurized

Treatment of patients with von Willebrand's disease



n/a 4/15/2005 Lorus Therapeutics, Inc.

Nexagon 4/27/2009 CoDa Therapeutics, Inc.

Atnativ 2/8/1985 Pharmacia & Upjohn AB

Antisense 20-mer oligonucleotide complementary to R2 component of ribonucleotide reductase mRNA


Antisense oligonucleotide directed against connexin43

Treatment of persistent corneal epithelial defects

Antithrombin III (human)

For the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.



Thrombate Iii 11/26/1984 Bayer Corporation

1/2/1986

Antithrombin III (human)

For replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli.

Antithrombin III human

Antithrombin Iii Human

Preventing or arresting episodes of thrombosis in patients with congenital AT-III deficiency and/or to prevent the occurrence of thrombosis in patients with AT-III deficiency who have undergone trauma or who are about to undergo surgery or parturition.

American National Red Cross



Antivipmyn 1/29/2004

Crofab 1/12/1994 Protherics, Inc.

n/a 2/12/1991

Apomorphine n/a 7/17/1995

Apomorphine HCl Apokyn 4/22/1993 US WorldMeds, LLC

Antivenin crotaline (pit-viper) equine immune F(ab)2)

Treatment of envenomation by Crotaline snakes

Rare Disease Therapeutics, Inc.

Antivenin, crotalidae polyvalent immune Fab (ovine)

Treatment of envenomations inflicted by North American crotalid snakes.

Antivenom (crotalidae) purified (avian)

Treatment of envenomation by poisonous snakes belonging to the Crotalidae family.

Ophidian Pharmaceuticals, Inc.

Treatment of the on-off fluctuations associated with late-stage Parkinson's disease.

Pentech Pharmaceuticals, Inc.

Treatment of the on-off fluctuations associated with late-stage Parkinson's disease.



n/a 5/23/2006Apomorphine hydrochloride

For the treatment of patients in a vegetative state or minimally conscious state for up to 12 months following a severe traumatic brain injury (traumatic or spontaneous)

NeuroHealing Pharmaceuticals, Inc.



Aprotinin Trasylol 11/17/1993 Bayer Corporation

Arenegyr n/a 8/22/2008 MolMed S.p.A.

Arginine butyrate n/a 4/7/1992 Perrine, Susan P., M.D.

Arsenic trioxide Trisenox 5/13/2003

For prophylactic use to reduce perioperative blood loss and the homologous blood transfusion requirement in patients undergoing cardiopulmonary bypass surgery in the course of repeat coronary artery bypass graft surgery, and in selected cases of primary coronary artery bypass graft surgery where the risk of bleeding is especially high (impaired hemostasis) or where transfusion is unavailable or unacceptable.

Treatment of malignant pleural mesothelioma

Treatment of beta-hemoglobinopathies and beta-thalassemia.


Teva Branded Pharmaceutical Products R&D, Inc.





Arsenic trioxide Trisenox 3/3/1998 Cephalon

Artesunate n/a 7/19/1999

Artesunate n/a 3/28/2006

Ascorbic acid Ascor L 500 8/31/2007

Asfotase alfa n/a 9/12/2008

Atovaquone Mepron 8/14/1991

Treatment of malignant glioma



TEVA Branded Pharmaceutical Products R & D, Inc.

Treatment of acute promyelocytic leukemia.

Treatment of malaria.

World Health Organization

Immediate treatment of malaria

US Army Medical Materiel Development Activity

Treatment of scurvy

McGuff Pharmaceuticals Inc.

Treatment of hypophosphatasia

Alexion Pharmaceuticals, Inc.

Prevention of Pneumocystis carinii pneumonia (PCP) in high-risk, HIV-infected patients defined by a history of one or more episodes of PCP and/or a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm3.

Glaxo Wellcome Research and Development



Atovaquone Mepron 9/10/1990 Glaxo Wellcome Inc.

n/a 4/27/2007 TVAX Biomedical, LLC

n/a 11/13/2014 Juno Therapeutics, Inc.

Treatment of AIDS associated Pneumocystis Carinii Pneumonia.

Attenuated autologous cancer cells and granulocyte macrophage colony stimulating factor in combination with activated autologous blood derived T-cells

Treatment of primary central nervous system malignancies

Autologous CD3+ T cells transduced with retroviral vector containing a chimeric antigen receptor directed against CD19 (Autologous CD3+ T cells containing CD19 chimeric antigen receptor)

Treatment of acute lymphoblastic leukemia (ALL)



n/a 4/30/2010

M-Vax 2/23/1999 Avax Technologies, Inc.

Permaderm 6/1/2012

n/a 1/31/2014

Autologous CD34+ cells transfected with lentiviral vector containing the human WAS cDNA (Telethon 003)

Treatment of Wiskott Aldrich syndrome

GlaxoSmithKline Intellectual Property Development

Autologous DNP-conjugated tumor vaccine

For adjuvant therapy in melanoma patients with surgically resectable lymph node metastasis (Stage III and limited Stage IV disease).

Autologous Engineered Skin Substitute

Treatment of hospitalized patients with deep partial and full thickness burns requiring grafting.

Amarantus BioScience Holdings, Inc.

Autologous T Cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19

For the treatment of Acute Lymphoblastic Leukemia




n/a 6/1/2007

Dcvax-Brain 11/29/2002

Cvac(Tm) 9/13/2010 Prima Biomed Ltd.

n/a 9/3/2004

Autologous cultured endothelial cells on a donor human corneal disk

Treatment of Fuch's dystrophy, pseudophakic bullous keratopathy, and bullous keratopathy

Cellular Bioengineering, Inc.

Autologous dendritic cells pulsed with autologous antigens from primay malignant brain tumor cells

Treatment of primary brain malignant cancer

Northwest Biotherapeutics, Inc.

Autologous dendritic cells pulsed with recombinant human fusion protein (mucin1- glutathione S transferase) coupled to oxidized polymannose


Autologous incubated macrophage

Therapy to improve the motor and sensory neurological outcome in acute cases of spinal cord injury

Proneuron Biotechnologies, Inc.



Biovaxid 10/18/2011 Biovest International, Inc.

Rhinocytes 2/1/2008 RhinoCyte, Inc.

n/a 7/14/2005 TissueTech, Inc.

n/a 7/12/1994 Cytogen Corporation

Azacitidine Vidaza 6/18/2008 Celgene Corporation

Azathioprine Imuran 9/14/1999 Oral Solutions, Inc.

n/a 5/17/2010 Bioprojet Pharma

Autologous lymphoma-derived immunoglobulin idiotype antigen vaccine conjugated to keyhole limpet hemocyanin

Treatment of Waldenstrom's macroglobulinemia

Autologous olfactory neural progenitors

Treatment of spinal cord injury patients with ASIA Impairment grades A, B, or C

Autologous or allogeneic limbal epithelial stem cells expanded ex vivo on human amniotic membrane

Treatment of ocular surface diseases that are characterized by total limbal stem cell deficiency

Autolymphocyte therapy

Treatment of renal cell carcinoma.


Treatment of oral manifestations of graft-versus-host disease.

BF2.649 (Pitolisant)

Treatment of narcolepsy



n/a 8/9/2006 OncoVac Corporation

Bacitracin Altracin 3/13/1984 A. L. Laboratories, Inc.

Baclofen 9/26/1994 Medtronic, Inc.

Colazal 8/12/2005

Bardoxolone n/a 8/6/2008

Basiliximab Simulect 12/12/1997

n/a 3/27/1998 Soligenix, Inc.

Bacillus Calmette-Guerin vaccine

Treatment of stage IIb through IV metastatic melanoma

Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.

Lioresal Intrathecal

Treatment of spasticity associated with cerebral palsy.

Balsalazide disodium

Treatment of pediatric patients with ulcerative colitis

Salix Pharmaceuticals, Inc.


Reata Pharmaceuticals, Inc.

Prophylaxis of solid organ rejection.


Beclomethasone dipropionate

For oral administration in the treatment of intestinal graft-versus-host disease.



Belinostat Beleodaq 9/3/2009

Treanda 8/17/2007 Cephalon, Inc.

n/a 11/5/2015 Exinda Theapeutics LLC

Ucephan 1/21/1986 ImmunexImmunex

Treatment of peripheral T-cell lymphoma (PTCL).

Spectrum Pharmaceuticals, Inc.

Bendamustine hydrochloride


Bendamustine oral doseage formulation


Benzoate and phenylacetate

For adjunctive therapy in the prevention and treatment of hyperammonemia in patients with urea cycle enzymopathy due to carbamylphosphate synthetase, ornithine, transcarbamylase, or argininosuccinate synthetase deficiency.



8/13/2001

Tantum 5/18/1998

Pre-Pen/Mdm 9/28/1987 AllerQuest LLC

Benzophenone-3, octylmethoxycinnamate, avobenzone, titanium dioxide, zinc oxide

Total Block Vl Spf 75

For the prevention of visible light induced skin photosensitivity as a result of porfimer sodium photodynamic therapy

Fallien Cosmeceuticals Ltd.

Benzydamine hydrochloride

Prophylactic treatment of oral mucositis resulting from radiation therapy for head and neck cancer.

Angelini Pharmaceuticals, Inc.

Benzylpenicillin, benzylpenicilloic, benzylpenilloic acid

Assessing the risk of administrating penicillin when it is the preferred drug of choice in adult patients who have previously received penicillin and have a history of clinical sensitivity.



Beractant 12/20/1993 Ross Laboratories

Beractant 2/5/1986 Ross Laboratories

Beraprost n/a 4/29/1999 LungRx, Inc.

Beta alethine Betathine 3/24/1997

Beta alethine Betathine 3/24/1997

Survanta Intratracheal Suspension

Treatment of full-term newborn infants with respiratory failure caused by meconium aspiration syndrome, persistent pulmonary hypertension of the newborn, or pneumonia and sepsis.

Survanta Intratracheal Suspension

Treatment of neonatal respiratory distress syndrome

Treatment of pulmonary arterial hypertension associated with any New York Heart Association classification (Class I, II, III, or IV).


Dovetail Technologies, Inc.


Dovetail Technologies, Inc.



n/a 11/8/2007

Betaine Cystadane 5/16/1994 Jazz Pharmaceuticals

Betulinic acid n/a 8/9/2007

Bexarotene Targretin 6/18/1999 Eisai, Inc.

Bindarit n/a 2/3/1998

n/a 4/27/2006 TissueTech, Inc.

Betahistine dihydrochloride

Treatment of obesity associated with Prader Willi syndrome

Floyd R. Sallee, M.D., Ph.D.

Treatment of homocystinuria.

Topical treatment of metastatic melanoma

Advanced Life Sciences, Inc. (ALS)

Treatment of cutaneous T-cell lymphoma.


Angelini Pharmaceuticals, Inc.

Bio-engineered oral mucosal tissue

For use as a graft for restoring a cornea-like epithelial phenotype to substitute for the normal corneal epithelium that is lost in patients due to total limbal stem cell deficiency



n/a 2/11/2002 Excorp Medical, Inc.

n/a 3/2/2000 ICAgen Inc.

Bleomycin n/a 12/20/2010 CIRJ Company Ltd.

Bleomycin Blenoxane 2/9/1999 Genetronics, Inc.

Bleomycin sulfate Blenoxane 9/17/1993

Blinatumomab n/a 5/16/2008 Amgen, Inc.

n/a 5/17/2010 t2cure GmbH

Bosentan Tracleer 10/6/2000

Bioartificial liver system utilizing xenogenic hepatocytes in a hollow fiber bioreactor cartridge (BAL)

Treatment of patients with acute liver failure presenting with encephalopathy deteriorating beyond Parson's grade 2

Bis(4-fluorophenyl)phenylacetamide

Treatment of sickle cell disease.



Treatment of malignant pleural effusion.

Bristol-Myers Squibb Pharmaceutical Research Institute


Bone marrow-derived mononuclear cells

Treatment of thromboangiitis obliterans (Buerger's disease)


Actelion Life Sciences Ltd.



Botox 3/22/1984 Allergan, Inc.


Dysport 3/23/1989 Porton International, Inc.

n/a 9/15/1992

Dysport 10/20/1999 Ipsen Limited

Dysport 8/12/1998 Ipsen Biopharm Limited

Botulinum toxin type A

Treatment of strabismus and blepharospasms


Treatment of cervical dystonia.


Treatment of essential blepharospasm.


Treatment of synkinetic closure of the eyelid associated with VII cranial nerve aberrant regeneration.

Botulinum Toxin Research Associates, Inc.


Treatment of dynamic muscle contractures in pediatric cerebral palsy patients.


Treatment of spasmodic torticollis (cervical dystonia).




Myobloc 1/16/1992

n/a 10/24/1991 Ipsen Limited

Babybig 1/31/1989

Bovine colostrum n/a 11/19/1990 Hastings, Donald DVM

Sporidin-G 3/1/1994 GalaGen, Inc.


Treatment of dynamic muscle contracture in pediatric cerebral palsy patients.

Botulinum toxin type B

Treatment of cervical dystonia.

Soltice Neurosciences, LLC

Botulinum toxin type F

Treatment of spasmodic torticollis (cervical dystonia).

Botulism immune globulin

Treatment of infant botulism.

California Department of Health Services

Treatment of AIDS-related diarrhea.

Bovine immunoglobulin concentrate, Cryptosporidium parvum

Treatment and symptomatic relief of Cryptosporidium parvum infection of the gastrointestinal tract in immunocompromised patients.



Immuno-C 9/30/1993 Biomune Systems, Inc.

n/a 12/23/1988

Brilliant Blue G Dorc Ilm-Blue 7/31/2012

Brimonidine Alphagan 2/7/2000 Allergan, Inc.

Bovine whey protein concentrate

Treatment of cryptosporidiosis caused by the presence of Cryptosporidium parvum in the gastrointestinal tract of patients who are immunodeficient/immunocompromised or immunocompetent.

Branched chain amino acids

Treatment of amyotrophic lateral sclerosis.

Mount Sinai Medical Center

To selectively stain the thickened internal limiting membrane, which has formed onto the inner side of the retina in vitreo-retinal disorders

Dutch Opthalmic Research Center

Treatment of anterior ischemic optic neuropathy.



Brivaracetam n/a 10/5/2005 UCB Pharma, Inc.

Broxuridine 9/18/1995 NeoPharm, Inc.

n/a 5/13/2015 Acerta Pharma BV

Bucillamine n/a 10/22/2015 Revive Therapeutics, Ltd.

Ursocarb 9/3/2004 Digestive Care, Inc.

8/24/1994 Lukare Medical, LLC

Subutex 6/15/1994

Treatment of symtomatic myoclonus

Broxine/Neomark

Radiation sensitizer in the treatment of primary brain tumors.

Bruton's Tyrosine Kinase (Btk) Inhibitor

Treatment of chronic lymphocytic leukemia (CLL).

Treatment of cystinuria

Buffered Ursodeoxycholic Acid

Treatment of pruritus in patients with Alagille Syndrome

Buffered intrathecal electrolyte/dextrose injection

Elliotts B Solution

For use as a diluent in the intrathecal administration of methotrexate and cytarabine for the prevention or treatment meningeal leukemia and lymphocytic lymphoma

Buprenorphine hydrochloride

Treatment of opiate addiction in opiate users.

Reckitt Benckiser Pharmaceuticals, Inc.



Busulfan Spartaject 4/21/1994

Busulfan Spartaject 7/7/1997 SuperGen, Inc.

Busulfan Busulfex 7/28/1994

n/a 10/5/2005

n/a 10/5/2005

For use as preparative therapy for malignancies treated with bone marrow transplantation.

Sparta Pharmaceuticals, Inc.

Treatment of primary brain malignancies.

As preparative therapy in the treatment of malignancies with bone marrow transplantation.

Otsuka Pharmaceutical Company

Buthionine sulfoxamine

Use as a modulator of chemotherapy for the treatment of pediatric patients with primary malignant brain tumors

USC-CHLA Institute for Pediatric Clinical Research

Buthionine sulfoxamine

For use in children as a modulator of chemotherapy for the treatment of pediatric patients with neuroblastoma




n/a 3/25/1992 Shire Laboratories Inc.

n/a 9/30/1992 Shire Laboratories Inc.

n/a 8/21/1996

Cinryze(R) 7/16/2004 Shire

Ruconest 2/23/1999 Santarus, Inc.

Berinert 10/16/1992 CSL Behring LLC

Butyrylcholinesterase

For the reduction and clearance of toxic blood levels of cocaine encountered during a drug overdose.

Butyrylcholinesterase

Treatment of post-surgical apnea.

C1 esterase inhibitor (human)

Treatment and prevention of angioedema caused by C1-esterase inhibitor deficiency.

Alpha Therapeutic Corporation

C1 esterase inhibitor (human)

Treatment of angioedema

C1-esterase inhibitor (recombinant)

Treatment of (acute attacks of) angioedema caused by hereditary or acquired C1-esterase inhibitor deficiency.

C1-esterase-inhibitor, human, pasteurized

Prevention and/or treatment of acute attacks of hereditary angioedema.



n/a 9/16/2010

C21H27O10P Minnelide 3/30/2015

C24H28N8O7S2 n/a 4/2/2015 Curis, Inc.

C66H100N6O27 n/a 3/11/2013 GenSpera, Inc.

n/a 12/20/2013 DiaVacs, Inc.

n/a 6/18/2012

Caffeine Cafcit 9/20/1988 O.P.R. Development, L.P.

Cibacalcin 1/20/1987

Calcium acetate Phos-Lo 12/22/1988

C20-D3-retinyl acetate

Treatment of Stargardt's disease

Alkeus pharmaceuticals, Inc.

Treatment of gastric cancer.

Minneamrita Therapeutics, LLC

Treatment of diffuse large B-cell lymphoma (DLBCL).

Treatment of of hepatocellular carcinoma

CD40/CD80/CD86 modified autologous dendritic cell therapy

Treatment Type 1 diabetes mellitus patients with residual beta cell function

CNDO-109-activated allogeneic natural killer cells


Coronado Biosciences, Inc.

Treatment of apnea of prematurity.

Calcitonin-human for injection

Treatment of symptomatic Paget's disease (osteitis deformans).

Novartis Pharmaceutical Corporation

Treatment of hyperphosphatemia in end stage renal failure.

Fresenius Medical Care North America



Calcium acetate n/a 6/27/1989 Pharmedic Company

6/6/1990 R & D Laboratories, Inc.

Calgonate 11/20/1997 Calgonate Corp.

H-F Gel 5/21/1991 Calgonate Corporation

n/a 9/10/1990

Capsaicin n/a 8/3/2005

Treatment of hyperphosphatemia in end stage renal disease.

Calcium carbonate

R & D Calcium Carbonate/600

Treatment of hyperphosphatemia in patients with end stage renal disease.

Calcium gluconate

For use as a wash for hydrofluoric acid spills on human skin.

Calcium gluconate gel

For use in the emergency topical treatment of hydrogen fluoride (hydrofluoric acid) burns.

Calcium gluconate gel 2.5%

Emergency topical treatment of hydrogen fluoride (hydrofluoric acid) burns.

Paddock Laboratories, Inc.

Treatment of postherpetic neuralgia.

TheraQuest Biosciences, LLC



Capsaicin n/a 9/29/2006 Centrexion Corporation

Carmustine n/a 7/3/2000 Direct Therapeutics, Inc.

n/a 3/21/1989 Intramed Corporation

Catumaxomab Removab 6/9/2006

Rocephin 3/28/2006 Mass General Hospital

Treatment of intermetatarsal neuroma (Morton's Neuroma) that does not respond to conservative treatment and requires either neurectomy or neurolysis

Treatment of intracranial malignancies.

Cascara sagrada fluid extract

Treatment of oral drug overdosage to speed lower bowel evacuation.


Neoviibiotech North America, Inc.

Ceftriaxone sodium




n/a 7/10/2002

Anascorp 6/12/2000

Fabrazyme 1/19/1988 Genzyme Corporation

n/a 2/10/1999 NeoRx Corporation

Chenofalk 1/29/2004 Dr. Falk Pharma GmbH

Cells produced using the AastromReplicelle System and SC-I Therapy Kit

For use in patients receiving high dose chemotherapy who are unable to generate an acceptable dose of peripheral blood stem cells and who have a sufficient bone marrow aspirate without morphological evidence of tumor

Aastrom Biosciences Incorporated

Centruroides immune F(ab)2

Treatment of scorpion envenomations requiring medical attention.

Rare Disease Therapeutics, Inc.

Ceramide trihexosidase/alpha-galactosidase A


Chelating agent delivering Holmium-166


Chenodeoxycholic acid

Treatment of cerebrotendinous xanthomatosis



n/a 10/4/2005

n/a 10/31/2006 Morphotek, Inc.

n/a 8/3/2000 Biosynexus, Inc.

Peridex 8/18/1986

Chlorotoxin n/a 12/18/2007 Morphotek, Inc.

Chimeric monoclonal antibodies, c-alphaStx2

For treatment of shiga-toxin producing bacterial infection

Thallion Pharmaceuticals, Inc.

Chimeric monoclonal antibody to mesothelin


Chimeric, humanized monoclonal antibody to staphylococcus

Prophylaxis of Staphylococcus epidermidis sepsis in low birth weight (1500 grams or less) infants.

Chlorhexidine gluconate mouthrinse

For use in the amelioration of oral mucositis associated with cytoreductive therapy used in conditioning patients for bone marrow transplantation therapy.

Procter & Gamble Company




Choline chloride Intrachol 2/10/1994 QOL Therapeutics EU Ltd

Choline chloride Intrachol 7/20/2006 QOL Therapeutics EU Ltd

n/a 12/1/1997 Curis, Inc.

n/a 1/30/1992

n/a 4/30/2010 Insys Therapeutics, Inc.

Treatment of choline deficiency, specifically the choline deficiency, hepatic steatosis, and cholestasis, associated with long-term parenteral nutrition.

Prevention and/or treatment of choline deficiency in patients on long-term parenteral nutrition

Chondrocyte-alginate gel suspension

For use in correcting vesicoureteral reflux in the pediatric population.

Ciliary neurotrophic factor


Regeneron Pharmaceuticals Inc

Cintredekin Besudotox




n/a 11/3/2015 Privo Technologies

3/20/2007

Intradose 4/3/2000

Intradose 9/7/2000

8/28/1989 United-Guardian, Inc.

Cladribine 11/15/1990

Cladribine Mylinax 4/19/1994

Cisplatin ChemoThin Wafer

Treatment of anatomically accessible oral cancers (lip, tongue, gum, floor of mouth, salivary gland, and other oral cavity)

Cisplatin in liposomal formulation

Slit Cisplatin For Inhalation

Treatment of osteosarcoma

Eleison Pharmaceuticals LLC

Cisplatin/epinephrine

Treatment of squamous cell carcinoma of the head and neck.

Matrix Pharmaceutical, Inc.

Cisplatin/epinephrine

Treatment of metastatic malignant melanoma.

Matrix Pharmaceutical, Inc.

Citric acid, glucono-delta-lactone and magnesium carbonate

Renacidin Irrigation

Treatment of renal and bladder calculi of the apatite or struvite variety.

Leustatin Injection

Treatment of hairy cell leukemia.

R. W. Johnson Pharmaceutical Research Institute

Treatment of the chronic progressive form of multiple sclerosis.

Johnson & Johnson Pharmaceutical R & D, LLC



Clazosentan Erajet 2/16/2006

Clindamycin Cleocin 10/28/1988 Pfizer Inc.

Clindamycin Cleocin 10/28/1988 Pharmacia & Upjohn

n/a 8/9/2006

Clofazimine Lamprene 6/11/1984

Clonazepam Klonopin 8/4/1994 Hoffmann-La Roche, Inc.

Treatment of cerebral vasospasm following subarachnoid hemorrhage

Actelion Pharmaceuticals Ltd.

Prevention of Pneumocystis carinii pneumonia in AIDS patients.

Treatment of Pneumocystis carinii pneumonia associated with AIDS patients.

Clindamycin hydrochloride

Treatment of sarcoidosis

Autoimmunity Research Foundation

Treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum.


Treatment of hyperekplexia (startle disease).



n/a 12/19/2007 Jazz Pharmaceuticals, Inc.

Clonidine Duraclon 1/24/1989 Roxane Laboratories, Inc.

Clotrimazole n/a 3/13/2006

Clotrimazole n/a 6/14/2005 AesRx, LLC

Clotrimazole n/a 4/24/1995 Brugnara, Carlo M.D.

Clonazepam Intranasal Spray

Treatment of recurrent acute repetitive seizures

For continous epidural administration as adjunctive therapy with intraspinal opiates for the treatment of pain in cancer patients tolerant to, or unresponsive to, intraspinal opiates.


EnVivo Pharmaceuticals, Inc.

Topical treatment of children and adults with pouchitis




Alphanine 7/5/1990

Benefix 10/3/1994 Genetics Institute, Inc.

Novoseven 7/16/2004 Novo Nordisk, Inc.

Mononine 6/27/1989

Coagulation Factor IX (human)

For use as replacement therapy in patients with hemophilia B for the prevention and control of bleeding episodes, and during surgery to correct defective hemostasis.


Coagulation Factor IX (recombinant)


Coagulation Factor VIIa (Recombinant)

Treatment of bleeding episodes in patients with acquired inhibitors to Factor VIII or Factor IX

Coagulation factor IX

Replacement treatment and prophylaxis of the hemorrhagic complications of hemophilia B.

Armour Pharmaceutical Company



Alprolix 10/30/2008 Biogen Idec Inc.




Coagulation factor IX (recombinant), Fc fusion protein

Control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease)

Coagulation factor VIIa (recombinant)

Treatment of bleeding episodes in patients with congenital factor VII deficiency


Prevention of bleeding episodes in patients with hemophilia A or B, with or without inhibitors


Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX.






Coenzyme Q10 n/a 3/5/2001

Colchicine n/a 9/25/2007 AR Scientific, Inc.


Prevention of bleeding episodes in patients with acquired inhibitors to Factor VIII or Factor IX


Prevention of bleeding episodes in Glanzmann's thrombasthenia


Prevention of bleeding episodes in patients with congenital Factor VII deficiency


Integrative Therapeutics, Inc.

Treatment of Behcet's Syndrome



10/20/1989 Glaxo Wellcome Inc.

n/a 10/9/2014

Colfosceril palmitate, cetyl alcohol, tyloxapol

Exosurf Neonatal For Intratracheal Suspension

1. Prevention of hyaline membrane disease, also known as respiratory distress syndrome, in infants born at 32 weeks gestation or less 2. prevention of hyaline membrane disease (HMD), also known as respiratory distress syndrome (RDS), in infants born at 32 weeks gestation or less and in the treatment of established HMO at all gestational ages.

Combination of nivolumab and ipilimumab

Treatment of Stage IIb to Stage IV melanoma




n/a 7/23/2003 OXiGENE, Inc

n/a 5/8/2006 OXiGENE, Inc.

n/a 8/6/2013

Contulakin-G n/a 7/7/2005 Cognetix, Inc.

Cordycepin n/a 7/5/2007 OncoVista, Inc.

Combretastatin A4 Phosphate

Treatment of anaplastic thyroid cancer, medullary thyroid cancer, and stage IV papillary or follicular thyroid cancer

Combretastatin A4 phosphate


Conjugate of a dengue virus specific small chemical ligand and an amphiphilic PEG based polymer

Treatment of dengue fever (includes dengue hemorrhagic fever and dengue shock syndrome)

NanoViricides Incorporated

Intrathecal treatment of neuropathic pain associated with spinal cord injury

Treatment of TdT-positive acute lymphocytic leukemia



Acthrel 11/24/1989 Ferring Laboratories, Inc.

Xerecept 4/6/1998

Coumarin Onkolox 12/22/1994 Drossapharm LTD

Cavatak 12/15/2005 Viralytics Limited

Creatine Creapure 10/11/2005

Cromolyn sodium Gastrocrom 3/8/1984 Fisons Corporation

7/24/1985 Fisons Corporation

n/a 12/30/1991 ImmuCell Corporation

Corticorelin ovine triflutate

For use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushings syndrome.

Corticotropin-releasing factor, human

Treatment of peritumoral brain edema.

Neurobiological Technologies, Inc.


Coxsackievirus A21

Treatment of stage II (T4), stage III, and stage IV melanoma


Marathon Pharmaceuticals, LLC

Treatment of mastocytosis.

Cromolyn sodium 4% ophthalmic solution

Opticrom 4% Ophthalmic Solution

Treatment of vernal keratoconjunctivitis.

Cryptosporidium hyperimmune bovine colostrum IgG concentrate

Treatment of diarrhea in AIDS patients caused by infection with Cryptosporidium parvum.



n/a 12/20/2006 Lux Biosciences, Inc.

Cyclosporin A Mitogard 10/29/2004 Maas Biolab,LLC

Cyclosporine n/a 11/25/2003 APT Pharmaceuticals, Inc.

Cyclosporine Pluminiq 11/25/2003 APT Pharmaceuticals, Inc.

Cyclo {{(E,Z)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)nona-6,8-dienoyl}-L-2-aminobytyrl-N-methyl-glycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl}

Treatment and chronic control of non-infectious posterior, intermediate and pan-uveitis

Treatment of amyotrophic lateral sclerosis and its variants

Prophylaxis of organ rejection in patients receiving allogeneic lung transplant

Treatment of acute rejection in patients requiring allogenic lung transplants



n/a 8/1/1991 Allergan, Inc.

Cyclosporine A n/a 5/4/2007 Santen SAS

n/a 12/6/2000 RTP Pharma Corporation

Optimmune 11/9/1988 University Of Georgia

n/a 2/14/2008

Cysteamine Lynovex 9/11/2014 NovaBiotics Ltd.

Cysteamine Cystagon 1/25/1991 Mylan Laboratories, Inc.

Cyclosporine 2% ophthalmic ointment

Treatment of patients at high risk of graft rejection following penetrating keratoplasty

Treatment of vernal keratoconjunctivitis

Cyclosporine in combination with omega-3 polyunsaturated fatty acids

Prevention of solid organ graft rejection.

Cyclosporine ophthalmic

Treatment of severe keratoconjunctivitis sicca associated with Sjogren's syndrome.

Cys-His-Ala-Val-Cys

For use in conjunction with melphalen for the treatment of malignant melanoma, AJCC stages IIB, IIC, III and IV

Adherex Technologies, Inc.


Treatment of nephropathic cystinosis.



Cysteamine n/a 5/1/1986 Thoene, Jess G., M.D.

Cystaran 8/19/1997

Adgvcftr.10 3/9/1995 GenVec, Inc.

n/a 1/8/1993 Genetic Therapy, Inc.

Depocyt 6/2/1993

n/a 8/22/2008

Treatment of nephropathic cystinosis.

Cysteamine hydrochloride

Treatment of corneal cystine crystal accumulation in cystinosis patients.


Cystic fibrosis Tr gene therapy (recombinant adenovirus)


Cystic fibrosis transmembrane conductance regulator gene


Cytarabine liposomal

Treatment of neoplastic meningitis.

Pacira Pharmaceuticals, Inc.

Cytarabine:daunorubicin liposome injection


Celator Pharmaceuticals, Inc.



n/a 9/23/2006 Vical Inc.

n/a 6/3/2005

Cytomegalovirus DNA Vaccine w/Copolymer/Benzalkonium Chloride

For use in prevention of clinically significant CMV viremia, CMV disease and associated complications in at-risk hematopoietic cell transplant and solid organ transplant populations

Cytomegalovirus DNA vaccine with plasmids expressing pp65 and gB genes

Prevention of clinically significant cytomegalovirus (CMV) viremia, CMV disease and associated complications in at-risk hematopoietic cell transplant and solid transplant populations

Astellas Pharma Global Development, Inc.



Cytogam 8/3/1987 CSL Behring LLC

n/a 1/28/1991 Bayer Corporation

Prodarsan 4/20/2009 DNage B.V.

D-peptide Nerofe 2/4/2011 Immune System Key, Ltd

Pulmadex 10/23/2002 Demegen, Inc.

DCVAC OvCa n/a 5/14/2013 SOTIOS a.s.

Cytomegalovirus immune globulin (human)

Prevention or attenuation of primary cytomegalovirus disease in immunosuppressed recipients of organ transplants.

Cytomegalovirus immune globulin intravenous (human)

For use in conjunction with ganciclovir sodium for the treatment of cytomegalovirus pneumonia in bone marrow transplant patients.

D-mannitol and L-proline

Treatment of Cockayne syndrome


D-peptide of the sequence AKRHHGYKRKFH - NH2





n/a 3/1/2004 Helsinn Healthcare SA

n/a 8/20/2009

n/a 2/6/2014 ViroMed Co., Ltd.

n/a 12/13/2010

n/a 7/24/2012

DEAE-rebeccamycin

Treatment of bile duct tumors

DNA plasmid expressing diphtheria toxin triggered by the presence of oncofetal gen H19


BioCancell Therapeutics Ltd.

DNA plasmid vector (pCK-HGFX7) expressing human hepatocyte growth factor


DNA plasmid vector expressing eIF5Ak50


Senesco Technologies, Inc.

DNA plasmid vector expressing eIF5Ak50R protein, siRNA directed against the nastive eIF5A mRNA, and PEI (polyethyleneimine)

Treatment of diffuse large B cell lymphoma




n/a 7/24/2012

n/a 4/4/2005 Celsion Corporation

Leuvectin 4/28/2000 Vical Incorporated

O-Vax 9/21/2000 AVAX Technologies, Inc.

DOXO-EMCH n/a 4/18/2011 CytRx Corporation

DPX-Survivac n/a 7/14/2015

DNA plasmid vector expressing eIF5Ak50R protein, siRNA directed against the native eIF5A mRNA, and PEI (polyethyleneimine)

Treatment of mantle cell lymphoma


DNA plasmid vector expressing human IL-12 gene


DNA-lipid complex (DMRIE/DOPE)/plasmid vector (VCL-1102, Vical) expressing human interleukin-2


DNP-Modified autologous tumor vaccine

Adjuvant therapy for the treatment of ovarian cancer

Treatment of adenocarcinoma of the pancreas.


Immunovaccine Technologies, Inc.



Daclizumab Zenapax 3/5/1993 Hoffmann-La Roche, Inc.

Dapsone n/a 11/7/1994

Dapsone USP Dapsone 1/8/1992

Dapsone USP Dapsone 12/24/1991

Darinaparsin n/a 9/13/2010 Solasia Pharma K.K.

Dasatinib Sprycel 11/28/2005

Prevention of acute renal allograft rejection.

Prophylaxis of toxoplasmosis in severely immunocompromised patients with CD4 counts below 100.

Jacobus Pharmaceutical Company, Inc.

For the combination treatment of Pneumocystis carinii pneumonia in conjunction with trimethoprim.


Prophylaxis for Pneumocystis carinii pneumonia.


Treatment of peripheral T-cell lymphoma.





Dasatinib Sprycel 11/18/2005

Daunoxome 5/14/1993

n/a 9/5/2008 Diatos USA, LLC

Deferasirox Exjade 11/21/2002

Defibrotide n/a 7/5/1985 Crinos International

Fidelin 8/19/2003 Paladin Labs, Inc.

n/a 1/29/1997 Pharmadigm, Inc.

Treatment of Philadelphia-positive acute lymphoblastic leukemia


Daunorubicin citrate liposome injection

Treatment of patients with advanced HIV-associated Kaposi's sarcoma.

NeXstar Pharmaceuticals, Inc.

Daunorubicin liposomal


Treatment of chronic iron overload in patients with transfusion-dependent anemias


Treatment of thrombotic thrombocytopenic purpura.

Dehydroepiandrosterone (DHEA)

Replacement therapy in individuals with adrenal insufficiency

Dehydroepiandrosterone sulfate sodium

Treatment of serious burns requiring hospitalization.



n/a 1/28/1997 Pharmadigm, Inc.

Dermagraft n/a 12/13/2010

Deslorelin Somagard 11/5/1987

n/a 10/26/2004 Peptimmune, Inc.

n/a 1/22/1991 Aventis Behring L.L.C.

Dexrazoxane Zinecard 12/17/1991 Pharmacia & Upjohn

Dehydroepiandrosterone sulfate sodium

To accelerate the re-epithelialization of donor sites in those hospitalized burn patients who must undergo autologous skin grafting.

Treatment of epidermolysis bullosa

Shire Regenerative Medicine, Inc.


Desmoglein 3 synthetic peptide (PI-0824)

Treatment of pemphigus vulgaris

Desmopressin acetate

Treatment of mild hemophilia A and von Willebrand's disease.

For the prevention of cardiomyopathy associated with doxorubicin administration.



Dextran 70 Dehydrex 3/5/1990 Holles Laboratories, Inc.

Bio-Rescue 3/8/1991 Biomedical Frontiers, Inc.

Uendex 10/5/1990 Kennedy & Hoidal, M.D.'s

n/a 11/19/1987

6/11/1992

Treatment of recurrent corneal erosion unresponsive to conventional therapy.

Dextran and deferoxamine

Treatment of acute iron poisoning.

Dextran sulfate (inhaled, aerosolized)

For use as an adjunct to the treatment of cystic fibrosis.

Dextran sulfate sodium

Treatment of aquired immunodeficiency syndrome.

Ueno Fine Chemicals Industry, Ltd.

Dianeal peritoneal dialysis solution with 1.1% amino acids

Nutrineal (Peritoneal Dialysis Solution With 1.1% Amino Acid

For use as a nutritional supplement for the treatment of malnourishment in patients undergoing continuous ambulatory peritoneal dialysis.

Baxter Healthcare Corporation



n/a 2/25/1992 Valeant Pharmaceuticals

Imuthiol 4/3/1986 Connaught Laboratories

n/a 4/28/2004

Diazepam viscous solution for rectal administration

For the management of selected, refractory, patients with epilepsy, on stable regimens of antiepileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizure activity.

Diethyldithiocarbamate

Treatment of AIDS.

Diethylenetriaminepentaacetic acid (DTPA)

Treatment of patients with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination.

Hameln Pharmaceuticals gmbh



Digibind 11/1/1984 Glaxo Wellcome Inc.

Digidote 3/11/1985

Androgel -Dht 2/5/1996

Digoxin immune FAB (Ovine)

Treatment of potentially life threatening digitalis intoxication in patients who are refractory to management by conventional therapy.

Digoxin immune fab(ovine)

Treatment of life-threatening acute cardiac glycoside intoxication manifested by conduction disorders, ectopic ventricular activity and (in some cases) hyperkalemia.

Boehringer Mannheim Corp.

Dihydrotestosterone

Treatment of weight loss in AIDS patients with HIV-associated wasting.

Besins Internaitonal, US Inc.



n/a 11/24/1999

n/a 11/22/1994

n/a 4/6/1998 Cancer Technologies, Inc.

n/a 4/15/1997 Cancer Technologies, Inc.

Dimerizing drug that binds to mutated Fas protein/drug-binding domain fusion protein (FKBP)

Treatment of acute graft-versus-host disease in patients undergoing bone marrow transplantation.

Bellicum Pharmaceuticals, Inc.

Dimethyl sulfoxide

Treatment of increased intracranial pressure in patients with severe, closed-head injury, also known as traumatic brain coma, for whom no other effective treatment is available.

Abela Pharmaceuticals, Inc.

Dimethylsulfoxide

Treatment of palmar-plantar erythrodysethesia syndrome.

Dimethylsulfoxide

Topical treatment for the prevention of soft tissue injury following extravastion of cytotoxic drugs.



Alec 7/28/1988 Forum Products, Inc.

4/15/2015

Immther 3/1/1990

n/a 6/16/1993

Bonefos 3/5/1990

Dipalmitoylphosphatidylcholine /phosphatidylglycerol

Prevention and treatment of neonatal respiratory distress syndrome.

Diphenylcyclopropenone gel

Samcyprone (Tm)

Treatment of malignant melanoma stage IIB to IV

RXi Pharmaceuticals Corp.

Disaccharide tripeptide glycerol dipalmitoyl

Treatment of pulmonary and hepatic metastases in patients with colorectal adenocarcinoma.

ImmunoTherapeutics, Inc.

Disodium clodronate

Treatment of hypercalcemia of malignancy.

Discovery Experimental & Development, Inc.

Disodium clodronate tetrahydrate

Treatment of increased bone resorption due to malignancy.

Anthra Pharmaceuticals, Inc.



Doripenem n/a 7/16/2004 Shionogi, Inc.

Dornase alfa Pulmozyme 1/16/1991 Genentech, Inc.

n/a 8/6/2010

n/a 10/7/2005 Supratek Pharma Inc.

Doxil 11/4/1998 Alza Corporation

Treatment of bronchopulmonary infection in patients with cystic fibrosis who are colonized with Pseudomonas aeruginosa or Burkholderia cepacia.

To reduce mucous viscosity and enable the clearance of airway secretions in patients with cystic fibrosis.

Double-stranded DNA plasmid carrying the gene for the diphtheria toxin A (DT-A) chain


BioCancell Therapeutics Israel Ltd.

Doxorubicin HCl with pluronic L-61 and pluronic F-127

Treatment of esophageal carcinoma

Doxorubicin liposome




Dronabinol Marinol 1/15/1991

Duramycin n/a 12/11/1997 Lantibio, Inc.

Dynamine n/a 2/5/1990 Mayo Foundation

Dynamine n/a 10/16/1991 Mayo Foundation

n/a 5/13/2015 GlycoMimetics, Inc.

Eculizumab n/a 9/21/2000

Edaravone n/a 5/12/2015

For the stimulation of appetite and prevention of weight loss in patients with a confirmed diagnosis of AIDS.

Unimed Pharmaceuticals, Inc.


Treatment of Lambert Eaton myasthenic syndrome.

Treatment of hereditary motor and sensory neuropathy type I (Charcot-Marie-Tooth disease).

E-selectin antagonist

Treatment of acute myeloid leukemia (AML)

Treatment of dermatomyositis



Mitsubishi Tanabe Pharma Corporation



Edotreotide Onalta(Tm) 7/28/2005

Efdispo (tm) Efdispo (Tm) 1/15/2013 TDP Biotherapeutics, Inc.

Eflornithine n/a 9/29/2006 Orbus Therapeutics, Inc.

Eflornithine HCl Ornidyl 4/23/1986 Hoechst Marion Roussel

Elcatonin n/a 9/25/1995 Innapharma, Inc.

Elesclomol n/a 12/18/2007

n/a 1/28/1997

Treatment of somatostatin receptor-positive neuroendocrine gastroenteropancreatic tumors

Molecular Insight Pharmaceuticals, Inc. (Progenics Subsidiary)

Treatment of Ewings Sarcoma.

Treatment of anaplastic glioma

Treatment of Trypanosoma brucei gambiense infection (sleeping sickness).

Intrathecal treatment of intractable pain.

Treatment of metastatic melanoma in combination with paclitaxel

Synta Pharmaceuticals Corporation

Enadoline hydrochloride

Treatment of severe head injury.

Warner-Lambert Company



Betarx 7/5/1995 VivoRx

n/a 2/6/2014

Enzastaurin n/a 9/19/2005 Denovo Biopharma LLC

n/a 10/5/1987 Chiron Vision

Epirubicin Ellence 9/14/1999

Epitalon n/a 9/2/2010 BioDiem Ltd

Encapsulated porcine islet preparation

Treatment of type I diabetic patients who are already on immunosuppression.

Engineered variant of recombinant human fibroblast growth factor 19


NGM Biopharmaceuticals, Inc.


Epidermal growth factor (human)

For acceleration of corneal epithelial regeneration and the healing of stromal tissue in the condition of non-healing corneal defects.

Treatment of breast cancer.

Pharmacia & Upjohn Company




Epoetin alfa Epogen 4/10/1986 Amgen, Inc.

Epoetin alfa n/a 12/20/1993

Epoetin alfa Epogen 7/1/1991 Amgen, Inc.

Epoetin alpha Procrit 3/7/1989

Epoetin alpha Procrit 8/27/1987

Epoetin beta Marogen 10/22/1987 Chugai-USA, Inc.

Epoprostenol Flolan 9/25/1985 Glaxo Wellcome Inc.

Treatment of anemia associated with end stage renal disease.

Treatment of myelodysplastic syndrome.

Johnson & Johnson Pharmaceutical Research & Dev.,

Treatment of anemia associated with HIV infection or HIV treatment.

Treatment of HIV associated anemia related to HIV infection or HIV treatment.





Treatment of primary pulmonary hypertension.



Eprodisate Kiacta(Tm) 4/6/1999

n/a 6/12/2014 FFCanVac Pte Ltd

Tarceva 7/18/2003 Genentech, Inc

Erwinase 7/30/1986 Jazz Pharmaceuticals, Inc.

n/a 8/19/1987 McDonnell Douglas Corp

Ethamolin 3/22/1984 QOL Medical

n/a 4/6/2000 Laxdale Ltd.

Treatment of secondary amyloidosis

C. T. Development America, Inc.

Epstein-Barr virus-specific autologous cytotoxic T lymphocytes

Treatment of Epstein-Barr virus positive head and neck cancers (which includes nasopharyngeal carcinoma)

Erlotinib Hydrochloride

Treatment of malignant gliomas

Erwinia L-asparaginase

Treatment of acute lymphocytic leukemia.

Erythropoietin (recombinant human)


Ethanolamine oleate

Treatment of patients with esophageal varices that have recently bled, to prevent rebleeding.

Ethyl eicosapentaenoate




Didronel 3/21/1986 MGI Pharma, Inc.

Etiocholanedione n/a 11/3/1995 SuperGen, Inc.

Etiocholanedione n/a 5/7/1996 SuperGen, Inc.

Prochymal(R) 12/14/2005 Mesoblast, Inc.

Exemestane Aromasin 9/19/1991 Pharmacia & Upjohn

Etidronate disodium

Treatment of hypercalcemia of malignancy inadequately managed by dietary modification and/or oral hydration.

Treatment of aplastic anemia.

Treatment of Prader-Willi syndrome.

Ex vivo cultured adult human mesenchymal stem cells

Treatment of acute graft versus host disease

Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.



Exisulind n/a 2/14/1994 OSI Pharmaceuticals, Inc.

n/a 11/5/2009

n/a 1/23/2013

n/a 8/25/2009

For the suppression and control of colonic adenomatous polyps in the inherited disease adenomatous polyposis coli.

Exon 44 specific phosphorothioate oligonucleotide

Treatment of Duchenne Muscular Dystrophy in patients who have a mutation correctable by skipping of exon 44of the dystrophin gene.

Prosensa Therapeutics B.V.


Treatment of Duchenne Muscular Dystrophy patients bearing mutations that can be corrected by skipping exon 45



Treatment of Duchenne Muscular Dystrophy.

Prosensa Therapeutics BV



n/a 1/23/2013

n/a 1/23/2013

n/a 5/14/2012

FTV1+GDP-fucose n/a 3/18/2011 America Stem Cell, Inc.

Exon 52 specific phosphorothiate oligonucleotide


Prosensa Therapeutics B V




Extract of sea cucumber, sea sponge, shark fin, sea urchin, and sargassum grass


Unicorn Pacific Corporation

To improve homing to bone (treatment of myeloablation) in patients receiving hematopoietic stem cell transplantation.



n/a 3/8/1995

n/a 5/21/2003

Fampridine Neurelan 6/2/1997 Acorda Therapeutics, Inc.

Felbamate Felbatol 1/24/1989 Wallace Laboratories

n/a 11/20/2006 Neuropharm, Ltd.

Fenretinide n/a 10/5/2005

Fenretinide n/a 4/7/2010 McGill University

n/a 2/1/2007 Kuros Biosurgery AG

Facilitated DNA Plasmid Vaccine

Treatment of cutaneous T cell lymphoma.

Wyeth-Lederle Vaccines and Pediatrics

Factor XIII [A2] homodimer, recombinant DNA origin

Treatment of congenital FXIII deficiency

Novo Nordisk Pharmaceuticals, INc.

Treatment of chronic, incomplete spinal cord injury.

Treatment of Lennox-Gastaut syndrome.

Fenobam hydrochloride

Treatment of fragile X syndrome

Treatment of neuroblastoma


Treatment of Pseudomonas aeruginosa lung infections in cystic fibrosis patients

Fibrin-based agent containing a N-terminally modified parathyroid hormone fragment TGplPTH1-34

Treatment of solitary (unicameral) bone cysts



n/a 8/23/1995

n/a 9/5/1988 Melville Biologics, Inc.

n/a 6/29/2011

Filgrastim Neupogen 10/1/1990 Amgen, Inc.

Fibrinogen (human)

For the control of bleeding and prophylactic treatment of patients deficient in fibrinogen.


Fibronectin (human plasma derived)

Treatment of non-healing corneal ulcers or epithelial defects which have been unresponsive to conventional therapy and the underlying cause has been eliminated.

Fibronectin Peptide

Prevention of burn injury progression of acute, deep dermal burns in hospitalized patients.

NeoMatrix Formulations, Inc.

Treatment of neutropenia associated with bone marrow transplants.






Treatment of patients with severe chronic neutropenia (absolute neutrophil count less than 500/mm3).

Reduction in the duration of neutropenia, fever, antibiotic use, and hospitalization, following induction and consolidation treatment for acute myeloid leukemia.

For use in the mobilization of peripheral blood progenitor cells for collection in patients who will receive myeloablative or myelosuppressive chemotherapy.



n/a 11/23/2010 Cleveland BioLabs, Inc.

Floxuridine, FUDR n/a 12/22/2004 Franco Muggia, M.D.

Fludara 4/18/1989 Berlex Laboratories, Inc.

Fludara 4/18/1989 Berlex Laboratories, Inc.

n/a 12/18/2007 Sanofi-Aventis U.S., Inc.

Flunarizine Sibelium 1/6/1986

FliC Flagellin Deletion Variant TLR5 Agonist

Prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster

Intraperitoneal treatment of gastric cancer.

Fludarabine phosphate

Treatment of chronic lymphocytic leukemia (CLL), including refractory CLL.

Fludarabine phosphate

Treatment and management of patients with non-Hodgkins lymphoma.

Fludarabine phosphate oral tablets

Treatment of B-cell chronic lymphocytic leukemia

Treatment of alternating hemiplegia.

Janssen Research Foundation



Fluocinolone Retisert 7/31/2000

Fluorouracil n/a 10/27/1989 Hoffmann-La Roche, Inc.

Fluorouracil n/a 4/18/1990 Hoffmann-La Roche, Inc.

Fluorouracil n/a 6/29/2000 Ethypharm SA

Fluoxetine Prozac 4/30/1999 Neuropharm, Ltd.

Fluoxetine Prozac 4/14/2004 Hollander, Eric MD

Treatment uveitis involving the posterior segment of the eye.

Bausch & Lomb Pharmaceuticals, Inc.

For use in combination with interferon alpha-2a, recombinant, for the treatment of esophageal carcinoma.

For use in combination with interferon alpha-2a, recombinant, for the treatment of advanced colorectal carcinoma.


Treatment of autism.

Treatment of body dysmorphic disorder in children and adolescents



Gonal-F 12/21/1998 EMD Serono, Inc.

Fomepizole Antizole 12/22/1988 Jazz Pharmaceuticals

Fosphenytoin Cerebyx 6/4/1991

Follitropin alfa, recombinant

For the initiation and re-initiation of spermatogenesis in adult males with reproductive failure due to hypothalamic or pituitary dysfunction, hypogonadotropic hypogonadism. AMENDED indication 6/27/00: For the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Treatment of methanol or ethylene glycol poisoning.

For the acute treatment of patients with status epilepticus of the grand mal type.




n/a 9/22/2008

Ni-0501 3/26/2010 NovImmune S.A.

n/a 1/11/2006

7/10/2002 Cancer Advances, Inc.

7/18/2002 Cancer Advances, Inc.

GNE Lipoplex n/a 11/13/2008 Gradalis, Inc.

n/a 3/26/2010 HIBM Research Group

Full Phosphorothioate Antisense Oligonucleotide against EWS-Fli-1 nanoparticles

Treatment of Ewing's sarcoma

The Cure Our Children Foundation

Fully human anti-interferon gamma monoclonal antibody

Treatment of hemophagocytic lymphohistiocytosis

Fusion protein consisting of human immunoglobim G1 constant region Fc region fused to the human receptor binding domain of ectodysplasin-A1

Treatment of X-linked hypohidrotic ectodermal dysplasia

Edimer Pharmaceuticals, Inc.

G17DT Immunogen

Gastrimmune(Tm)

Treatment of adenocarcinoma of the pancreas

G17DT Immunogen

Gastrimmune(Tm)

Treatment of gastric cancer

Treatment of hereditary inclusion body myopathy-2

GNE plasmid(H001)

Treatment of hereditary inclusion body myopathy type 2



GVAX melanoma n/a 12/23/2010 Aduro BioTech, Inc.

n/a 7/1/2015

n/a 12/31/2013

n/a 10/25/2013

Treatment of stage IIb to IV melanoma

Gallium (68Ga) edotreotide

Diagnostic for the clinical management of neuroendocrine tumors.

Advanced Accelerator Applications, USA

Gallium [Ga-68]-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-L-cysteinyl-L-threonine-cyclic(2-7)disulfide

Diagnostic for the Management of Gastro-Entero-Pancreatic Neuroendocrine Tumors

Advanced Accelerator Applications

Gallium-68 (DOTA0-Phel-Tyr3)octreotide

The management of neuroendocrine tumors

University of Iowa Hospital & Clinics



n/a 12/3/1987 Biocraft Laboratories, Inc.

n/a 7/27/1994 Zurier, Robert B. M.D.

Ganaxolone n/a 5/25/1994

6/7/1995

n/a 7/7/2009 Astrimmune Ltd.

Mylotarg 11/24/1999

Gamma hydroxybutyrate

Treatment of narcolepsy and the auxiliary symptoms of cataplexy, sleep paralysis, hypnagogic hallucinations and automatic behavior.

Gammalinolenic acid

Treatment of juvenile rheumatoid arthritis.


Marinus Pharmaceuticals, Inc.

Ganciclovir intravitreal implant

Vitrasert Implant

Treatment of cytomegalovirus retinitis.

Bausch & Lomb Surgical, Chiron Vision Products

Gastrin 17C Diphtheria Toxoid Immunogen


Gemtuzumab zogamicin

Treatment of CD33-positive acute myeloid leukemia.

Wyeth-Ayerst Laboratories



n/a 12/11/1997

Geneticin n/a 6/6/2005 ProcesScience, Inc (PSI)

Septopal 1/31/1991

Maitec 7/10/1990 Liposome Company, Inc.

Copaxone 11/9/1987

Copaxone 6/5/2001

Genetically engineered human recombinant IgG4 monoclonal antibody directed against human TNF alpha

Treatment of Crohn's disease.

Celltech Chiroscience Limited

Treatment of amoebiasis.

Gentamicin impregnated PMMA beads on surgical wire

Treatment of chronic osteomyelitis of post-traumatic, postoperative, or hematogenous origin.

Lipha Pharmaceuticals, Inc.

Gentamicin liposome injection

Treatment of disseminated Mycobacterium avium-intracellulare infection.

Glatiramer acetate

Treatment of multiple sclerosis.

Teva Pharmaceuticals USA

Glatiramer acetate for injection

Treatment of primary-progressive multiple sclerosis




Glutamine Nutrestore 3/6/1995 Emmaus Medical, Inc.

n/a 8/16/2010 to-BBB technologies BV

n/a 5/24/2005 Ucyclyd Pharma, Inc

n/a 2/14/1995 Moser, Hugo W. M.D.

Proenzy 4/30/2010 BPT Pharmaceuticals, Inc.

For use with human growth hormone in the treatment of short bowel syndrome (nutrient malabsorption from the gastrointestinal tract resulting from an inadequate absorptive surface).

Glutathione pegylated liposomal doxorubicin hydrochloride

Treatment of glioma

Glyceryl tri (4-phenylbutyrate)


Glyceryl trioleate and glyceryl trierucate

Treatment of adrenoleukodystrophy.

Glyeraldehyde-3-phosphate dehydrogenase

Treatment of pediatric multiple sclerosis



Lutrepulse 4/22/1987 Ferring Laboratories, Inc.

Gossypol n/a 10/22/1990

n/a 3/25/1997 Genzyme Corporation

n/a 8/7/1989

Gonadorelin acetate

For induction of ovulation in women with hypothalamic amenorrhea due to a deficiency or absence in the quantity or pulse pattern of endogenous GnRH secretion.

Treatment of cancer of the adrenal cortex.

Reidenberg, Marcus M. M.D.

Gp100 adenoviral gene therapy


Growth hormone releasing factor

For the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.

Valeant Pharmaceuticals North America



n/a 12/22/2011 CanBas Company, Ltd.

n/a 9/20/2012 Immuno Tech, Inc.

n/a 4/11/2014 NoNO, Inc.

n/a 5/14/2013 NoNO, Inc.

HIRMAb-IDS n/a 5/15/2013

H-(D)p-Benzoylphenylalanyl-(D)seryl-(D)tryptophanyl-(D)seryl-(D)pentafluorophenylalanyl-(D)cyclohexylalanyl-(D)arginyl-(D)arginyl-(D)arginyl-(D)glutaminyl-(D)arginyl-(D)arginine acetate salt

For use in combination with cisplatin and pemetrexed for the treatment of patients with mesothelioma

H-Leu-Pro-Pro-Ser-Arg-OH

Treatment of Kaposi sarcoma

H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-Lys-Leu-Ser-Ser-Ile-Glu- Ser-Asp-Val-OH

Treatment of acute ischemic stroke patients presenting within 3 hours of symptom onset

H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-alys-aleu-Ser-Ser-Ile-Glu-Ser-Asp-Val-OH

Treatment of subarachnoid hemorrhage

Treatment of mucopolysaccharidosis Type II (Hunter Syndrome)

ArmaGen Technologies, Inc.



Allovectin-7 9/30/1999 Vical Incorporated

n/a 1/12/2009 Gliknik, Inc.

n/a 9/1/2011 ISA Therapeutics BV

Halofantrine Halfan 11/4/1991

Halofuginone Stenorol 2/7/2000

Hanferon Hanferon 3/9/2012

HLA-B7/Beta2M DNA Lipid (DMRIE/DOPE) Complex

Treatment of invasive and metastatic melanoma (Stages II, III, and IV).

HPV-16 cancer therapeutic trojan peptide vaccine

Treatment of HPV-16 expressing head and neck squamous cell carcinoma.

HPV16 E6/E7 synthetic long peptides vaccine

Treatment of epithelial neoplasias of the vulva positive for human papilloma virus type 16.

Treatment of mild to moderate acute malaria caused by susceptible strains of P. falciparum and P. vivax.

SmithKline Beecham Pharmaceuticals


Collgard Biopharmaceuticals Ltd.

Treatment of Behcet's disease

HanAll BioPharma Co., Ltd.



n/a 11/13/2012

Diapep277 5/21/2012 AndromedA Biotech, LTD

n/a 3/18/2011 ALS Biopharma, LLC

Heme arginate Normosang 3/10/1988 Orphan Europe SARL

Heme arginate Normosang 3/1/1994 Orphan Europe

Hantaan virus and Puumala virus DNA vaccines

Prevention of hemorrhagic fever with renal syndrome caused by Hantaan virus and Puumala virus.

Surgeon General of the U. S. Army

Heat Shock Protein (hsp60) antigen

For use in type 1 diabetic mellitus patients with residual beta-cell function

Heat Shock Protein 70


Treatment of symptomatic stage of acute porphyria.




Hemin Panhematin 3/16/1984 Abbott Laboratories

Hemex 12/20/1993

n/a 12/18/2007 Apex Bioscience, Inc.

Heparin sodium n/a 6/29/2006 Ockham Biotech Limited

Amelioration of recurrent attacks of acute intermittent porphyria (AIP) temporarily related to the menstrual cycle in susceptible women and similar symptoms which occur in other patients with AIP, porphyria variegata and hereditary coproporphyria.

Hemin and zinc mesoporphyrin

Treatment of acute porphyric syndromes.

Bonkovsky, Herbert L. M.D.

Hemoximer (pyridoxalated hemoglobin polyoxyethylene)

Treatment of cardiogenic shock




n/a 9/18/2006

Nabi-Hb 3/8/1995

Civacir(Tm) 11/14/2002

n/a 4/18/2011 Isis Pharmaceuticals, Inc.


n/a 3/11/2013 ONL Therapeutics, Inc

Heparin-binding epidermal growth factor-like growth factor

Prevention and treatment of necrotizing enterocolitis (NEC) in preterm infants with birth weight less than 1,500 grams

Trillium Therapeutics, Inc.

Hepatitis B immune globulin intravenous (human)

Prophylaxis against hepatitis B virus reinfection in liver transplant patients.

Biotest Pharmaceuticals Corporation

Hepatitis C virus immune globulin (human)

Prophylaxis of hepatitis C infection in liver transplant recipients.


Heptadecasodium salt of an 18-base residue phosphorothioate oligonucleotide


Herpes simplex virus gene

Treatment of primary and metastatic brain tumors.

His-His-Ile-Tyr-Leu-Gly-Ala-Val-Asn-Tyr-Ile-Tyr

Treatment of retinal detachment



Histamine Maxamine 2/1/2000 EpiCept Corporation

Histamine Ceplene 12/15/1999 EpiCept Corporation

Histrelin n/a 5/3/1991 Anderson, Karl E., M.D.

Histrelin Supprelin La 11/18/2005

Histrelin acetate 8/10/1988

Remitogen 11/28/2001 PDL BioPharma, Inc.

For use as an adjunct to cytokine therapy in the treatment of malignant melanoma.

Adjunct to cytokine therapy in the treatment of acute myeloid leukemia.

Treatment of acute intermittent porphyria, hereditary coproporphyria, and variegate porphyria.

Treatment of central precocious puberty

Endo Pharmaceuticals Solutions, Inc.

Supprelin Injection

Treatment of central precocious puberty.


Hu1D10, humanized monoclonal antibody

For use in the treatment of 1D10+ B cell non-Hodgkin's lymphoma



n/a 9/12/2008 Mesoblast, Inc.

Human Hemin n/a 8/6/2013

n/a 5/29/2014 AbbVie, Inc.

Vaxsyn Hiv-1 11/20/1989 MicroGeneSys, Inc.

Human Allogeneic HLA-matched, Umbilical Cord Blood Hematopoietic Progenitor Cells Ex Vivo Expanded on Allogeneic Mesenchymal Precursor Cells

Treatment of insufficient hematopoietic stem cell production in patients with hematologic malignancies who have failed treatment with conventional chemotherapy.

Prevention of ischemia reperfusion injury in patients undergoing solid organ transplantation

Borders Technology Management Ltd

Human Monoclonal Antibody against Epidermal Growth Factor Receptor Linked to Monomethylauristatin F


Human T-lymphotropic virus type III Gp160 antigens

Treatment of AIDS.



n/a 4/4/2005

n/a 9/27/2004 Bristol-Myers Squibb, Inc.

n/a 3/24/2008 Bone Therapeutics S.A.

n/a 12/20/2006

Human factor X n/a 11/8/2007 Bio Products Laboratory

3/29/2006 Instituto Grifols, S.A.

Human alpha 2,6 sialyltransferase adenoviral gene therapy

Treatment of patients with invasive (malignant) brain and central nervous system tumors lacking alpha 2,6 sialyltransferase.

Falk Center for Molecular Therapeutics

Human anti-CD30 monoclonal antibody

Treatment of Hodgkin's disease

Human autologous bone-forming cell derived from bone marrow stem cells

Treatment of osteonecrosis

Human cytomegalovirus immunoglobulin

Prevention of congenital cytomegalovirus (CMV) infection following primary CMV infection in pregnant women


Treatment of hereditary factor X deficiency

Human immune globulin

Flebogamma(R) 5% Dif

Treatment of post-polio syndrome



n/a 1/10/2006 Bristol-Myers Squibb

n/a 11/2/2004 CuraGen Corporation

Aerumab 11 9/18/2006 Kenta Biotech Limited

n/a 12/16/2013 Omeros Corporation

n/a 4/30/2010 Ortho Biotech

Human immunoglobin anti-CD30 monoclonal antibody

Treatment of CD30+ T-cell lymphoma

Human monoclonal antibody against platelet-derived growth factor D

To slow the progression of IgA nephropathy and delay kidney failure in patients affected by the disease.

Human monoclonal antibody directed against serotype 011 Pseudomonas aeruginosa

Treatment of hospital acquired pneumonia caused by serotype 011 positive Pseudomonas aeruginosa

Human monoclonal antibody inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2)

Prevention (inhibition) of complement-mediated thrombotic microangiopathy

Human monoclonal antibody targeting CC-chemokine ligand 2 (CNTO 888)




Wilate 4/18/2007 Octapharma USA, Inc.

n/a 4/30/2014 Cambryn Biologics

Octaplex 2/1/2008 Octapharma USA, Inc.

Human plasma coagulation Factor VIII and human plasma von Willebrand Factor

Treatment of von Willebrand disease except for surgical and/or invasive procedures in patients with von Willebrand disease in whom desmopressin is either ineffective or contraindicated

Human plasma derived conagulation protein-Factor XI

For the treatment of congenital Factor XI deficiency

Human prothrombin complex concentrate

Reversal of anticoagulation therapy in patients needing treatment of serious or life threatening bleeding and/or needing urgent surgery or invasive procedures



n/a 7/20/2006 GemVax A/S

n/a 6/24/2013

n/a 9/29/2006 MacroGenics, Inc.

Zenapax 3/5/1993 Hoffmann-La Roche, Inc.

n/a 4/29/2011 Morphotek

Human telomerase reverse transcriptase peptide vaccine


Humanized 3F8-IgG1 monoclonal antibody


Memorial Sloan-Kettering Cancer Center

Humanized anti-CD3 monoclonal antibody

Treatment of recent-onset Type I diabetes

Humanized anti-tac

Prevention of acute graft-vs-host disease following bone marrow transplantation.

Humanized monoclonal antibody to TumorEndothelial Marker-1




Hydralazine n/a 4/9/2004 Bioniche Pharma USA LLC

n/a 9/22/2000 Jazz Pharmaceuticals

Cyanokit 11/25/2003 SERB, S.A.

Trappsol 5/17/2010 Sphingo Biotech, LLC

Hydroxyurea Droxia 10/1/1990

Treatment of severe intrapartum hypertension (diastolic blood pressure greater than or equal to 110 or systolic blood pressure greater than or equal to 160) associated with severe preeclampsia/eclampsia of pregnancy

Hydroxocobalamin

Treatment of acute cyanide poisoning

Hydroxocobalamin

Treatment of acute cyanide poisoning

Hydroxy-Propyl-Beta-Cyclodextrin

Treatment of Niemann Pick Disease, Type C

Treatment of patients with sickle cell anemia as shown by the presence of hemoglobin S.




Hypericin n/a 2/7/2000 Soligenix, Inc.

Hypericin n/a 8/3/2000 HyBiopharma, Inc.

Meveol 11/5/2009


Agt-181 1/10/2008

n/a 6/24/2013 Activartis Biotech GmbH

n/a 4/6/2000

Salprofen 10/29/1996 Farmacon-IL, LLC

Ibuprofen lysine Neoprofen 10/29/1996 Lundbeck, Inc.



Hypothiocyanite and lactoferrin


Alaxia Biotechnologies Sante

I(131)-TM-601 (chlorotoxin)


IDUA-HIRMAb fusion protein

Treatment of mucopolysaccharidosis Type 1 (MPS)

ArmaGen Technologies, Inc.

IL-12 secreting dendritic cells loaded with autologous tumor lysate


IL-4 Pseudomonas Toxin Fusion Protein (IL-4(38-37)-PE38KDEL)

Treatment of astrocytic glioma.

Medicenna Therapeutics, Inc.

Ibuprofen i.v. solution

Prevention of patent ductus arteriosus.

Treatment of patent ductus arteriosus



7/18/1997

Idamycin 7/25/1988 Adria Laboratories, Inc.

Idoxuridine n/a 4/8/1996 NeoPharm, Inc.

Ifosfamide Ifex 1/20/1987

n/a 6/22/2011

Ventavis 8/17/2004 CoTherix, Inc.

Imatinib Gleevec 1/31/2001

Icodextrin 7.5% with Electrolytes Peritoneal Dialysis Solution

Extraneal (With 7.5% Icodextrin) Peritoneal Dialysis Solutio

Treatment of those patients having end stage renal disease and requiring peritoneal dialysis treatment.


Idarubicin HCl for injection

Treatment of acute myelogenous leukemia, also referred to as acute nonlymphocytic leukemia.

Treatment of nonparenchymatous sarcomas.

Treatment of testicular cancer.


IgG1 chimeric monoclonal antibody


Immune System Therapeutics Ltd

Iloprost inhalation solution






Imatinib mesylate Gleevec 8/25/2005



Myoscint 1/25/1989 Centocor, Inc.

Imexon n/a 11/8/1996 AmpliMed Corporation

Treatment of idiopathic hypereosinophilic syndrome including acute and chronic eosinophilic leukemia


Treatment of myeloproliferative disorders/myelodysplastic syndromes associated with platelet-derived growth factor gene re-arrangements


Treatment of systemic mastocytosis without the D816V c-kit mutation


Imciromab pentetate

Detecting early necrosis as an indication of rejection of orthotopic cardiac transplants.




Imiglucerase Cerezyme 11/5/1991 Genzyme Corporation

Imiquimod n/a 12/3/2014 Telormedix SA

Elad 7/16/2004 Vital Therapies, Inc.

Gamunex(R)-C 7/27/2004 Grifols Therapeutics, Inc.

3/17/2004

Carimune Nf 5/4/2004 ZLB Bioplasma AG

Replacement therapy in patients with types I, II, and III Gaucher's disease.

Treatment of carcinoma in situ (CIS) of the urinary bladder

Immortalized human liver cells found in the extracorporeal liver assist device

Treatment of fulminant hepatic failure (acute liver failure)

Immune Globulin (Human)

Treatment of chronic inflammatory demyelinating polyneuropathy

Immune Globulin (Human) containing high titers of West Nile virus antibodies

Omr-Igg-Am (Tm) 5% (Wnv)

Treatment of the West Nile virus infection

OMRIX Biopharmaceuticals, Ltd.

Immune Globulin Intravenous (human)

Treatment for Guillain Barre Syndrome



Hizentra 8/18/2014 CSL Behring

Gamimune N 2/18/1993 Bayer Corporation

n/a 3/16/1994 Cytel Corporation

Immune Globulin Subcutaneous (Human), 20% Liquid

Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)

Immune globulin intravenous, human

Infection prophylaxis in pediatric patients affected with the human immunodeficiency virus.

Immunotherapeutic vaccine consisting of (PAM)2-Lys-Ser-Ser-Gln-Tyr-Ile-Lys-Ala-Asn-Ser-Lys-Phe-Ile-Gly-Ile-Thr-Glu-Ala-Ala-Ala-Phe-Leu-Pro-Ser-Asp-Phe-Phe-Pro-Ser-Val

Treatment of chronic active hepatitis B infection in HLA-A2 positive patients.



n/a 5/12/1992 ALK Laboratories, Inc.

n/a 1/10/2006

6/16/2006

Inecalcitol n/a 5/14/2014 Hybrigenics, S.A.

Infliximab Remicade 5/21/2003 Centocor, Inc.

Infliximab Remicade 11/12/2003 Centocor, Inc.

n/a 1/29/2010

Imported fire ant venom, allergenic extract

For skin testing of victims of fire ant stings to confirm fire ant sensitivity and if positive, for use as immunotherapy for the prevention of IgE-mediated anaphylactic reactions.

Inalimarev and falimarev

Treatment of adenocarcinoma of the pancreas

Therion Biologics Corporation

Indium-111 pentetreotide

Neuroendomedix

Treatment of neuroendocrine tumors

RadioIsotope Therapy of America (RITA) Foundation


Treatment of chronic sarcoidosis

Treatment of pediatric (0 to 16 years of age) Crohn's Disease

Inhibitor of Tissue Factor Pathway Inhibitor (TFPI)

Treatment of hemophilia A and hemophilia B.

Baxter Healthcare Corporation, Baxter BioScience



n/a 10/2/2014

Inosine pranobex Isoprinosine 9/20/1988

Interferon alfa-2a Roferon A 6/6/1989 Hoffmann-La Roche, Inc.

Roferon-A 5/11/1990 Hoffmann-La Roche, Inc.




Inhibitor of primary and secondary KIT and PDGFR alpha kinase mutants found in GIST

Treatment of gastrointestinal stromal tumors (GIST)


Treatment of subacute sclerosing panencephalitis.

Newport Pharmaceuticals


Interferon alfa-2a (recombinant)

For the treatment of metastatic malignant melanoma in combination with Teceleukin.




Treatment of AIDS related Kaposi's sarcoma.


For use in combination with fluorouracil for the treatment of esophageal carcinoma.





Intron A 6/24/1987 Schering Corporation

Avonex 12/16/1991 Biogen, Inc.

Rebif 3/11/1996 EMD Serono, Inc.

n/a 7/24/1992 Biogen, Inc.


For the concomitant administration with Teceleukin for the treatment of metastatic renal cell carcinoma.


For the concomitant administration with fluorouracil for the treatment of advanced colorectal cancer.

Interferon alfa-2b (recombinant)


Interferon beta-1a


Interferon beta-1a

Treatment of patients with secondary progressive multiple sclerosis.

Interferon beta-1a (recombinant human)

Treatment of acute non-A, non-B hepatitis.



Rebif 12/2/1992 EMD Serono, Inc.

Betaseron 11/17/1988

n/a 10/11/2007

Actimmune 9/30/1988

Actimmune 12/4/1995

Actimmune 9/30/1996

n/a 4/17/2001 Ernest C.Borden

Interferon beta-1a (recombinant)

Treatment of symptomatic patients with AIDS including all patients with CD4 T-cell counts less than 200 cells per mm3.

Interferon beta-1b


Chiron Corp. & Berlex Laboratories

Interferon gamma


mondoBIOTECH Laboratories AG

Interferon gamma 1-b

Treatment of chronic granulomatous disease.

Horizon Pharma Ireland Limited

Interferon gamma-1b



Interferon gamma-1b

Delaying time to disease progression in patients with severe, malignant osteopetrosis.


Interferon-alfa-1b




n/a 4/4/2005

Antril 10/16/1992

Antril 9/23/1991

Interleukin-2 Teceleukin 2/5/1990 Hoffmann-La Roche, Inc.

Interleukin-2 Teleleukin 2/6/1990 Hoffmann-La Roche, Inc.


Interleukin-1 Trap

Treatment of Still's disease including juvenile rheumatoid arthritis and adult-onset Still's disease

Regeneron Pharmaceuticals, Inc.

Interleukin-1 receptor antagonist, human recombinant

Prevention and treatment of graft versus host disease in transplant recipients.

Swedish Orphan Biovitrum AB (publ) (SOBI)

Interleukin-1 receptor antagonist, human recombinant



Treatment of metastatic renal cell carcinoma.

Treatment of metastatic malignant melanoma.

In combination with interferon alfa-2a for the treatment of metastatic malignant melanoma.




Ifrs 7/31/2001 Digestive Care, Inc.

Vitigam 7/26/2007 GammaCan Ltd.

Octagam(R) 7/31/2008 Octapharma USA, Inc.

Iobenguane I 123 Adreview 12/1/2006 GE Healthcare, Inc.

Iobenguane I 123 Adreview 12/1/2006 GE Healthcare, Inc.

Iobenguane I 131 1/18/2006

In combination with interferon alfa-2a for the treatment of metastatic renal cell carcinoma.

Intraoral fluoride releasing system

Prevention of dental caries due to radiation-induced xerostomia in patients with head and neck cancer

Intravenous immune globulin

Treatment of Stage IIB to IV malignant melanoma

Intravenous immune globulin (human) 10%

Treatment of stiff-person syndrome

For the diagnosis of neuroblastomas

For the diagnosis of pheochromocytomas

Azedra Ultratrace


Molecular Insight Pharmaceuticals



Omaclear 10/17/2005

n/a 8/1/1984 David E. Kuhl, M.D.

n/a 11/7/1988 Immunomedics, Inc.

Pentacea 2/22/2000

131ichtnt-1 2/12/1999

Iobenguane Sulfate I-123

For scintigraphic detection, localization and staging of neuroblastoma.

Brogan Pharmaceuticals, LLC

Iodine 131 6B-iodomethyl-19-norcholesterol

For use in adrenal cortical imaging.

Iodine I 123 murine monoclonal antibody to hCG

Detection of hCG producing tumors such as germ cell and trophoblastic cell tumors.

Iodine I 131 bis(indium-diethylenetriaminepentaacetic acid)tyrosyllysine/hMN-14 x m734 F(ab')2 bispecific monoclonal antibody

Treatment of small-cell lung cancer.

IBC Pharmaceuticals, L.L.C.

Iodine I-131 radiolabeled chimeric MAb tumor necrosis treatment (TNT-1B)

Treatment of glioblastoma multiforme and anaplastic astrocytoma.

Peregrine Pharmaceuticals, Inc.



Ipatasertib n/a 4/30/2014 Genentech, Inc.

Isobutyramide n/a 5/25/1994

Isobutyramide 12/18/1992 Perrine, Susan P., M.D.

n/a 10/30/2008

n/a 5/19/1999 Glovax Co., Ltd.

Ixiaro 9/25/2012 Intercell AG

For the treatment of gastric cancer including cancer of the gastro-esophageal junction.

Treatment of sickle cell disease and beta thalassemia.


Isobutyramide Oral Solution

Treatment of beta-hemoglobinopathies and beta-thalassemia syndromes.

Itraconazole suspension

Topical treatment of fungal otitis externa (otomycosis)

Fairfield Clinical Trials, LLC

Japanese encephalitis vaccine (live, attenuated)

Prevention of Japanese encephalitis.

Japanese encephalitis vaccine, inactivated, adsorbed

Prevention of Japanese encephalitis virus in pediatric patients.



Kre-Celazine n/a 4/1/2013

Procysteine 6/14/1994

Procysteine 7/30/1996

n/a 11/1/1984 Watson Laboratories, Inc.

n/a 1/20/1999 Watson Laboratories, Inc.

n/a 1/12/2011 Immunopath Profile, Inc.

n/a 1/18/2006 CepTor Corporation


Treatment of juvenile rheumatoid arthritis joint and related tissue inflammation in the pediatric population

All American Pharmaceutical & Natural Foods Corpor

L-2-oxothiazolidine-4-carboxylic acid

Treatment of adult respiratory distress syndrome.

Transcend Therapeutics, Inc.

L-2-oxothiazolidine-4-carboxylic acid


Transcend Therapeutics, Inc.

L-5 Hydroxytrytophan

Treatment of postanoxic intention myoclonus.

L-5-hydroxytryptophan

Treatment of tetrahydrobiopterin deficiency.

L-amino acids, vitamins and minerals combined with omega-3 fatty acids

Treatment of patients with pediatric Crohn's disease

L-aminocarnityl-succinyl-leucyl-argininal-diethylacetal

Treatment of Duchenne and Becker muscular dystrophy

L-arginyl-L-isoleucyl-L-valyl-L-prolyl-L-alanine-amide

Treatment of acute radiation syndrome



L-asparaginase n/a 3/27/2014 ERYTECH Pharma S.A.

Graspa 1/6/2010 Erytech Pharma

Graspa 7/6/2012 ERYTECH Pharma

L-baclofen Neuralgon 1/30/1992

L-baclofen n/a 12/17/1991

L-baclofen n/a 7/13/1990 Fromm, Gerhard M.D.

L-baclofen n/a 1/6/1998

L-cycloserine n/a 8/1/1989 Lev, Meir M.D.


L-asparaginase encapsulated in red blood cells


L-asparaginase encapsulated in red blood cells


Treatment of intractable spasticity in children with cerebral palsy.

Osmotica Pharmaceutical Corp.

Treatment of spasticity associated with spinal cord injury or multiple sclerosis.


Treatment of trigeminal neuralgia.



Treatment of Gaucher's disease.



L-cysteine n/a 5/16/1994

L-glutamine n/a 8/1/2001 Emmaus Medical, Inc.

n/a 10/20/1999

n/a 4/7/2010 Ocera Therapeutics, Inc.

n/a 9/18/2009

n/a 9/13/2011

For the prevention and lessening of photosensitivity in erythropoietic protoporphyria.

Brigham and Women's Hospital


L-glutamyl-L-tryptophan


Implicit Bioscience Pty Ltd

L-ornithine phenylacetate

Treatment of hyperammonemia and resultant hepatic encephalopathy (HE) in patients with acute liver failure or acute on chronic liver disase

L-pyr-L-glu-L-gln-L-leu-L-glu-L-arg-L-ala-L-leu-L-asn-L-ser-L-ser

Prevention of delayed graft function following renal transplant

Araim Pharmaceuticals, Inc.

L-pyr-L-glu-L-gln-L-leu-L-glu-L-arg-L-ala-L-leu-L-asn-L-ser-L-ser

Treatment of neuropathic pain in patients with sarcoidosis.

Araim Pharmaceuticals, Inc.



n/a 4/26/2005

Cms-024 9/10/2004

L. reuteri n/a 8/1/2013

n/a 5/4/2015 Lokon Pharma AB

L-threonyl-L-prolyl-L-prolyl-L-threonine

Treatment of neuropathic pain associated with spinal cord injury

Nyxis Neurotherapies, Inc.

L-tyrosine-L-serine-L-leucine


CMS Peptides Patent Holding Company Limited

Prevention of necrotizing enterocolitis in preterm infants with birth weight less than or equal to 1,500 grams

Infant Bacterial Therapeutics

LOAd703, a modified adenovirus 5/35 containing a CMV promoter-driven transgene cassette with the human transgenes for a membrane-bound CD40 ligand (TMZ-CD40L) and full length 4-1BBL




Lactic acid Aphthaid 6/29/1999

n/a 3/24/2015

Lamotrigine Lamictal 8/23/1995

Lanreotide 9/11/2000 IPSEN, Inc.

Laromustine Cloretazine 3/27/2014 Nanotherapeutics, Inc.

Analatro 6/18/2001

Treatment of severe aphthous stomatitis in severely, terminally immunocompromised patients.

Frontier Pharmaceutical, Inc.

Lactobacillus acidophilus and Bifidobacterium animalis subsp. lactis

Prevention of necrotizing enterocolitis (NEC) in premature infants with very low birth weight less than or equal to 1500 grams



Glaxo Wellcome Research and Development

Somatuline Depot

Treatment for acromegly


Latrodectus immune F(ab)2

Treatment of black widow spider envenomations

Instituto Bioclon, S.A. de C.V.



Leflunomide n/a 10/18/1996 Williams, MD, James W.

Stargen (Tm) 4/30/2010 Sanofi US Services, Inc.

Ushstat(Tm) 5/17/2010 Sanofi US Services, Inc.

Thalagen 1/11/2006

Lepirudin Refluden 2/13/1997 Hoechst Marion Roussel

Lestaurtinib n/a 3/24/2006

Prevention of acute and chronic rejection in patients who have received solid organ transplants.

Lentiviral vector containing the human ABCA4 gene

Treatment of Stargardt disease

Lentiviral vector containing the human MY07A gene

Treatment of retinitis pigmentosa associated with Usher syndrome 1B gene defect.

Lentiviral vector encoded with a human beta-globin gene plasmid

Treatment of beta-thalassemia major and beta-thalassemia intermedia


Treatment of heparin-associated thrombocytopenia type II.





Leucovorin 12/8/1986 Immunex Corporation

Leucovorin 8/17/1988 Immunex Corporation

Leupeptin n/a 9/18/1990

7/25/1988 Tap Pharmaceuticals, Inc.

Levocarnitine Carnitor 2/28/1984


Leucovorin Calcium

For use in combination with 5-fluorouracil for the treatment of metastatic colorectal cancer.

Leucovorin Calcium

For rescue use after high dose methotrexate therapy in the treatment of osteosarcoma.

For use as an adjunct to microsurgical peripheral nerve repair.

Neuromuscular Adjuncts, Inc.

Leuprolide acetate

Lupron Injection


Treatment of genetic carnitine deficiency.


Treatment of primary and secondary carnitine deficiency of genetic origin.







Duodopa 1/18/2000 AbbVie, Inc.

Levofloxacin n/a 2/27/2008

Treatment of manifestations of carnitine deficiency in patients with end stage renal disease who require dialysis.


Treatment of zidovudine-induced mitochondrial myopathy.


Treatment of pediatric cardiomyopathy.


Levodopa and carbidopa

Treatment of late stage Parkinson's disease

Treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis patients

Forest Research Institute, Inc.



Levoleucovorin Fusilev 8/1/1991

Orlaam 1/24/1985

10/24/1995 Teikoku Pharma USA, Inc.

Triostat 7/30/1990

n/a 4/30/2010 Your Energy Systems, LLC

For use in conjunction with high-dose methotrexate in the treatment of osteosarcoma.


Levomethadyl acetate hydrochloride

Treatment of heroin addicts suitable for maintenance on opiate agonists.

Biodevelopment Corporation

Lidocaine patch 5%

Lidoderm Patch

For relief of allodynia (painful hypersensitivity), and chronic pain in postherpetic neuralgia.

Liothyronine sodium injection

Treatment of myxedema coma/precoma.


Liposomal Glutathione

Support of glutathione deficiency in individuals with inborn errors of metabolism of glutathione (IEMG)



Immther 6/10/1998 Endorex Corp.

Immther 6/10/1998 Endorex Corp.

Ambisome 12/10/1996 Fujisawa USA, Inc.



n/a 6/17/2005

n/a 6/17/2005

n/a 4/19/2006 Aradigm Corporation


Liposomal N-Acetylglucosminyl-N-Acetylmuramly-L-Ala-D-isoGln-L-Ala -gylcerolidpalmitoyl

Treatment of osteosarcoma.

Liposomal N-Acetylglucosminyl-N-Acetylmuramly-L-Ala-D-isoGln-L-Ala -gylcerolidpalmitoyl

Treatment of Ewing's sarcoma.

Liposomal amphotericin B

Treatment of cryptococcal meningitis.


Treatment of visceral leishmaniasis.


Treatment of histoplasmosis.

Liposomal annamycin



Liposomal annamycin



Liposomal ciprofloxacin for inhalation

Management of cystic fibrosis

Liposomal ciprofloxacin for inhalation

Management of bronchiectasis



Lipova-Pt 5/23/2006

Cyclospire 4/30/1998 Vernon Knight, M.D.

Sarcodoxome 12/27/2006 GP-Pharm SA

Nyotran 6/13/2000 The University of Texas

n/a 11/25/1991

n/a 6/20/1994

Liposomal cisplatin



Liposomal cyclosporin A

For aerosolized administration in the prevention and treatment of lung allograft rejection and pulmonary rejection events associated with bone marrow transplantation.

Liposomal doxorubicin hydrochloride

Treatment of soft tissue sarcomas

Liposomal nystatin

Treatment of invasive fungal infections.

Liposome encapsulated recombinant interleukin-2

Treatment of brain and CNS tumors.

Oncothyreon Canada, Inc.

Liposome encapsulated recombinant interleukin-2

Treatment of cancers of the kidney and renal pelvis

Oncothyreon Canada, Inc.



Lisofylline n/a 6/10/1999 Cell Therapeutics, Inc.

3/24/2015 Aduro BioTech, Inc.

10/16/1991 Alcon Laboratories, Inc.

Lonafarnib n/a 11/19/2013

Lucinactant Surfaxin 7/17/1995

Lucinactant 10/21/2010


Treatment of patients undergoing induction therapy for acute myeloid leukemia.

Live-attenuated Listeria monocytogenes actA/inlB/human mesothelin (hMeso) Strain hMeso38

Not Determined

Treatment of mesothelioma.

Lodoxamide tromethamine

Alomide Ophthalmic Solution

Treatment of vernal keratoconjunctivitis.

Treatment of Hepatitis Delta Virus (HDV)infection

Eiger Biopharmaceuticals, Inc.

Treatment of acute respiratory distress syndrome in adults.

Discovery Laboratories, Inc.

Surfaxin(R), Aerosurf(R)



Treatment of bronchopulmonary dysplasia in premature infants.






MA09-hRPE cells n/a 2/2/2010

n/a 11/24/2008 Gliknik, Inc.

n/a 2/4/2011

n/a 2/4/2011

Cea-Cide 9/18/1998 Immunomedics, Inc.

Prevention of bronchopulmonary dysplasia in premature infants

Discovery Laboratories, Inc

Treatment of respiratory distress syndrome in premature infants.


Treatment of Stargardt's macular dystrophy.

Advanced Cell Technology, Inc.

MAGE-A3 cancer therapeutic Trojan peptide vaccine

Treatment of MAGE-A3 expressing head and neck squamous cell carcinoma

MLN4924-Inhibitor of Nedd8-activating enzyme (NAE)

Treatment of acute myelogenous leukemia.

Millennium Pharmaceuticals

MLN4924-Inhibitor of Nedd8-activating enzyme (NAE)

Treatment of Myelodysplastic syndrome


MN14 monoclonal antibody to carcinoembryonic antigen

Treatment of small cell lung cancer




n/a 9/29/2010 OPKO Biologics Ltd.

n/a 1/3/2001 FeRx Incorporated

n/a 9/23/2014

7/18/1990 Mylan Laboratories, Inc.

Mafosfamide n/a 1/21/2003

MN14 monoclonal antibody to carcinoembryonic antigen


MOD-423 hGH analogue

Treatment of growth hormone deficiency

MTC-DOX for Injection


MV-NB-02, its bivalent ganglioside vaccine consisting of GD2-lactone and GD3-lactone each covalently conjugated to keyhole hemocyanin

Treatment of Neuroblastoma

MabVax Therapeutics, Inc.

Mafenide acetate solution

Sulfamylon Solution

For use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Treatment of neoplastic meningitis




n/a 2/27/2008 Galera Therapeutics, LLC

Mannitol Bronchitol 2/11/2005 Pharmaxis Ltd.

Marijuana n/a 5/25/1999

Marizomib n/a 12/13/2013

Galardin 12/5/1991 Glycomed, Inc

MaxAdFVIII n/a 3/3/2003

Mazindol Sanorex 12/8/1986 Collipp, Platon J. M.D.

Mecamylamine Inversine 10/14/1998 Targacept, Inc.

Manganese superoxide dismutase mimetic

Prevention of radiation- or chemotherapy-induced oral mucositis in cancer patients

For use to facilitate clearance of mucus in patients with bronchiectasis and in patients with cystic fibrosis at risk for bronchiectasis

Treatment of HIV-associated wasting syndrome.

Multidisciplinary Association for Psychedelic Studies, Inc.


Triphase Research and Development I Corp.

Matrix metalloproteinase inhibitor

Treatment of corneal ulcers.

Treatment of Hemophilia A

GenStar Therapeutics Corporation

Treatment of Duchenne muscular dystrophy.

Treatment of Tourette's syndrome.



Mecasermin Increlex 12/12/1995

Hematrol 2/22/2001

Mefloquine HCl Mephaquin 7/22/1987 Mepha AG

Megace 4/13/1988

n/a 9/6/2006 Caladrius Biosciences

Canvaxin 10/13/1994 CancerVax Corporation

Treatment of growth hormone insensitivity syndrome.

Ipsen Biopharmaceuticals, Inc.

Medroxyprogesterone acetate

Treatment of immune thrombocytopenic purpura.

ZaBeCor Pharmaceutical Company, LLC

Treatment and prevention of chloroquine-resistant Falciparummalaria

Megestrol acetate

Treatment of patients with anorexia, cachexia, or significant weight loss (=/>10% of baseline body weight) and confirmed diagnosis of AIDS.


Melanoma autologous dendritic cell vaccine

Treatment of stage IIIb through IV metastatic melanoma

Melanoma cell vaccine

Treatment of invasive melanoma.



n/a 3/29/2005

Melacine 12/20/1989

Melatonin n/a 11/15/1993 Sack, Robert, M.D.

Melatonin Circadin 7/9/2004

Melphalan 2/24/1992 Glaxo Wellcome Inc.

n/a 5/14/2014 IC-MedTech Corporation

Melanoma peptide vaccine

Treatment of HLA-A2+ patients with stage IIB, IIC, III, and IV malignant melanoma

Bristol-Myers Squibb Research Inst

Melanoma vaccine

Treatment of stage III - IV melanoma.

Ribi ImmunoChem Research, Inc.

Treatment of circadian rhythm sleep disorders in blind people with no light perception.

Treatment of non-24-hour sleep-wake disorder in blind individuals without light perception

Neurim Pharmaceuticals, Ltd.

Alkeran For Injection

Treatment of patients with multiple myeloma for whom oral therapy is inappropriate.

Menadione Sodium Bisulfite

For the treatment of autosomal dominant polycystic kidney disease



Mesna Mesnex 11/14/1985 Degussa Corporation

n/a 8/21/1996 Genopia USA, Inc.

Methotrexate Amethopterin 8/28/2014

Methotrexate 10/21/1985 Lederle Laboratories

10/15/1990 Echo Therapeutics, Ltd.

Methoxsalen Uvadex 10/14/1998 Therakos, Inc.

For use as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.

Methionine/L-methionine

Treatment of AIDS myelopathy.

Treatment of Myasthenia Gravis

The Universtiy of Kanasa Medical Center

Methotrexate sodium

Treatment of osteogenic sarcoma.

Methotrexate with laurocapram

Methotrexate/Azone

Topical treatment of mycosis fungoides.

For use in conjunction with the UVAR photopheresis system to treat graft versus host disease.



n/a 4/18/2011 Endotis Pharma

Metronidazole Metrogel 10/24/1991

Metrogel 10/22/1987

n/a 11/8/2007 SLA Pharma (UK) Ltd

11/16/1990 Cav-Con, Inc.

Methyl O-4-O-[2-[2-[2-[2-[[N-[(1R)-1-[[4-(aminoiminomethyl)phenyl]methyl]-2-oxo-2-(1-piperidinyl)ethyl]-N2-[(4-methoxy-2,3,6-trimethylphenyl)sulfonyl]-L-Ã?ÂÃÃ?Ã?Â&Ã?ÃÂ½Ã?ÂÃÃ?ÂÃ?ÃÂ±-aspararginyl-4-aminobutanoyl-N6-[5-[(3aS,4S,6aR)-hexahydro-2-oxo-1H-thieno[

Prevention of ischemia reperfusion injury associated wth solid organ transplantation

Treatment of perioral dermatitis.

Galderma Laboratories, Inc.

Metronidazole (topical)

Treatment of acne rosacea.

Galderma Laboratories, Inc.

Metronidazole 10% ointment

Topical treatment of active perianal Crohn's disease

Microbubble contrast agent

Filmix Neurosonographic Contrast Agent

Intraoperative aid in the identification and localization of intracranial tumors.



n/a 1/25/2007 Thrombotargets Corp.

n/a 10/11/2007 Thrombotargets Corp.

Midodrine HCl Amatine 6/21/1985 Shire

Midostaurin Rydapt 4/30/2010 Novartis Oncology

Midostaurin n/a 7/7/2009

Microvesiculated modified glycosylated tissue factor

Treatment of non-life threatening, mild to severe bleeding episodes due to cutaneous injuries or dental procedures in hemophiliac patients

Microvesiculated modified glycosylated tissue factor

Treatment of non-life threatening, mild to severe bleeding episodes due to cutaneous injuries or dental procedures in patients with von Willebrand disease.

Treatment of patients with symptomatic orthostatic hypotension.

Treatment of mastocytosis





Mifepristone n/a 2/7/2005 HRA Pharma

Minnelide Minnelide (Tm) 2/18/2013

n/a 3/28/2006

Mitoguazone Apep 3/18/1994 ILEX Oncology, Inc.

Mitolactol n/a 7/12/1995 Targent, Inc.

Mitolactol n/a 1/23/1989 Targent, Inc..

Mitomycin-C n/a 8/20/1993 IOP Inc.

Treatment of Cushing's syndrome secondary to ectopic ACTH secretion


Minneamrita Therapeutics, LLC

Minocycline hydrochloride

Treatment of sarcoidosis

Autoimmunity Research Foundation

Treatment of diffuse non-Hodgkin's lymphoma, including AIDS-related diffuse non-Hodgkin's lymphoma.

As adjuvant therapy in the treatment of primary brain tumors.

Treatment of invasive carcinoma of the uterine cervix

Treatment of refractory glaucoma as an adjunct to ab externo glaucoma surgery.



Mitoxantrone Novantrone 8/21/1996 Serono

Mitoxantrone Novantrone 8/13/1999 Serono, Inc.

Mitoxantrone Novantrone 8/13/1999 Serono, Inc.

Mitoxantrone HCl Novantrone 7/13/1987 Lederle Laboratories

n/a 10/7/2015

Mocetinostat n/a 6/12/2014 Mirati Therapeutics, Inc.

Modafinil Provigil 3/15/1993 Cephalon, Inc.

Treatment of hormone refractory prostate cancer.

Treatment of progressive-relapsing multiple sclerosis.

Treatment of secondary-progressive multiple sclerosis.

Treatment of acute myelogenous leukemia, also referred to as acute nonlymphocytic leukemia.

Mixture of 2 anti-rabies humanized monoclonal immunoglobulin (Ig)G1k antibodies

Post-exposure prophylaxis against rabies virus infection

Synermore Biologics Co., Ltd


Treatment of excessive daytime sleepiness in narcolepsy.



n/a 1/7/1993 VivoRx Autoimmune, Inc.

11/25/1996 Quest PharmaTech, Inc.

Monolaurin Glylorin 4/29/1993 Glaxo Wellcome Inc.

U-Cord-Cell(R) 9/15/2015

Monooctanoin Moctanin 5/30/1984

Infumorph 7/12/1990 Elkins-Sinn, Inc.

Monoclonal antibody for immunization against lupus nephritis


Monoclonal antibody-B43.13

Ovarex Mab-B43.13

Treatment of epithelial ovarian cancer.

Treatment of congenital primary ichthyosis.

Mononuclear enriched fraction of human umbilical cord blood

Treatment of amyotrophic lateral sclerosis (ALS).

Saneron CCEL Therapeutics, Inc.

For dissolution of cholesterol gallstones retained in the common bile duct.

Ethitek Pharmaceuticals, Inc.

Morphine sulfate concentrate (preservative free)

For use in microinfusion devices for intraspinal administration in the treatment of intractable chronic pain.



n/a 7/27/2004

n/a 6/23/2013 OncoPep, Inc.

n/a 12/12/1989

Multistem(r) n/a 9/15/2010 Athersys, Inc.

Oncolym 11/27/1998

Multi-ligand somatostatin analog

Treatment of patients with functional gastroenteropancreatic (GEP) neuroendocrine tumors (specifically, carcinoid, insulinoma, gastrinoma, somastatinoma, GRFoma, VIPoma and glucagonoma.


Multi-peptide cancer vaccine


Multi-vitamin infusion (neonatal formula)

For establishment and maintenance of total parenteral nutrition in very low birth weight infants.

Astra Pharmaceuticals, L.P.

Prophylaxis of graft vs host disease

Murine MAb (Lym-1) and Iodine 131-I radiolabeled murine MAb (Lym-1) to human B-cell lymphoma

Treatment of B-cell non-Hodgkin's lymphoma.

Peregrine Pharmaceuticals, Inc.



Theragyn 3/22/1999 Antisoma plc

Mx-dnG1 Rexin-G(R) 6/24/2008

Mx-dnG1 Rexin-G 6/24/2008

Rexin-G 8/15/2003

n/a 10/11/1995 Statens Seruminstitut

n/a 10/29/2015 Donald J. Krogstad, MD

n/a 4/6/2012 CTI Science Limited

Murine MAb to polymorphic epithelial mucin, human milk fat globule 1

Adjuvant treatment of ovarian cancer.


Epeius Biotechnologies Corporation



Mx-dnG1 or Rexin-G retroviral vector



Mycobacterium avium sensitin RS-10

For use in the diagnosis of invasive Mycobacterium avium disease in immunocompetent individuals.

N'-(7-Chloroquinolin-4-yl)-N,N-diethyl-propane-1,3-diamine

Treatment of malaria.

N,N'-bis(2-mercaptoethyl)isophthalamide (NBMI)

Treatment of mercury toxicity



n/a 11/17/2014

n/a 11/17/2014 Bionure Farma SL

n/a 2/1/2008 Mirati Therapeutics, Inc.

N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide


Catabasis Pharmaceuticals, Inc.

N-(2-amino-2-oxoethyl)-2-(2-((4-fluorophenethyl)amino)-N-isobutylacetamido)-N-(3-(2-oxopyrrolidin-1-yl)propyl)acetamide N-({Carbamoylmethyl-[3-(2-oxo-pyrrolidin-1-yl)propyl}-carbamoyl}-methyl)-2-[2-(2-fluorophenyl)-ethylamino]-N-isobutyl-acetamide

Treatment of optic neuritis

N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide dihydrobromide




n/a 8/8/2007 Mirati Therapeutics, Inc.

n/a 9/4/2014

n/a 10/15/2014 ProteoTech, Inc.

n/a 11/26/2013

N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide dihydrobromide

Treatment of Hodgkin's lymphoma

N-(2-{2-dimethylaminoethyl-methylamino}-4-methoxy-5-{[4-(1-methylindol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide mesylate salt

Treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer


N-(3,4-dihydroxyphenyl)-3,4-dihydroxybenzamide

Treatment of AL Amyloidosis

N-(3-fluorobenzyl)-2-(5-(4-morpholinophenyl) pyridin-2-yl) Acetamide Besylate

Treatment of gliomas

Kinex Pharmaceuticals, Inc.



n/a 7/6/2012 BioLineRx, Ltd.

n/a 10/21/2014 Amgen, Inc.

n/a 3/18/2009

N-(4-Fluoro-benzoyl)-L-arginyl-L-arginyl-[L-3-(naphthyl-alanyl]-L-cysteinyl-L-tyrosyl-L-citrullinyl-L-lysyl-D-lysyl-L-prolyl-L-trosyl-L-arginyl-L-citrullinyl-L-cysteinyl-L-aginine amide, cyclic (4-13)-disulfide

For use in combination with G-CSF to mobilize HSCs from the marrow to peripheral blood for collection for autologous or allogeneic transplantation

N-(4-{3-(2-aminopyrimidin-4-yl)pyridin-2-yl]oxy}phenyl)-4-(4-methylthiophen-2-yl)phthalazin-1-amine bis-mesylate dihydrate


N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt


Ambit Biosciences Corporation



n/a 11/17/2014 Unither Virology, LLC


n/a 10/17/2005 AB Science

n/a 4/5/2010 Altamira Bio, Inc. (ABIO)

n/a 1/13/2012 Arno Therapeutics, Inc.

N-(9-methoxynonyl)-1-deoxynojirimycin hydrochloride

Treatment of acute dengue illness (inclusive of acute dengue illness, dengue fever, dengue hemorrhagic fever, and dengue shock syndrome)

N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl(phenyl]amino}pyrimidin-4-yl)benzamide

Treatment of myelofibrosis

N-(methyl-diazacyclohexyl-methylbenzamide)-azaphenyl-aminothiopyrrole) mesylate


N-Acetylmannosamine (ManNAc)

Treatment of hereditary inclusion body myopathy type 2

N-Hydroxy-4-(3-methyl-2-(S)phenyl-butyrylamino)benzamide

Treatment of meningioma



n/a 1/13/2012 Arno Therapeutics, Inc.

n/a 10/15/2014

n/a 1/29/2010 EMD Serono, Inc.


n/a 1/7/2015 Atterocor, Inc.

N-Hydroxy-4-(3-methyl-2-(S)phenyl-butyrylamino)benzamide

Treatment of Schwannoma of the central nervous system

N-Methanocarbathymidine

Treatment of neonatal herpes

N & N Pharmaceuticals, Inc.

N-[(2S)-2,3-dihydroxypropyl]-3-[(2-fluoro-4-iodophenyl)amino] isonicotinamide hydrochloride


N-[(2S)-2,3-dihydroxypropyl]-3-[(2-fluoro-4-iodophenyl)amino] isonicotinamide hydrochloride

Treatment of acute myeloid leukemia (AML).

N-[2,6-bis(1-methylethyl)phenyl]-N'-[[1-[4-(dimethylamino)phenyl]cyclopentyl]methyl]urea, hydrochloride salt

For the treatment of Cushing's Syndrome



n/a 12/27/2006 CytRx Corporation



n/a 2/3/2015 Ignyta, Inc.

N-[3-(4',5'-bipyrimidin-2-ylamino)-4-methylphenyl]-4-{[(3S)-3-(dimethylamino)pyrrolidin-1-yl]methyl}-3-(trifluoromethyl)benzamide

Treatment of Philadelphia chromosome-positive chronic myelogenous leukemia.

N-[4-(trifluoromethyl)phenyl] 5 methylisoxazole-4-carboxamide


N-[4-(trifluoromethyl)phenyl]-5-methylisoxazole-4-carboxamide


N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide

Treatment of TrkA-positive, TrkB-positive, TrkC-positive ROS1-positive or ALK-positive non-small cell lung cancer




n/a 12/31/2013 Brighton Biotech, Inc.

n/a 2/6/2006 ExSAR Corporation

n/a 12/10/1996 NAPA of the Bahamas

12/27/2000

N-acetylcysteine n/a 9/9/2002

N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide

Treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive, or ALK-positive colorectal cancer

N-acetyl cysteine amide


N-acetyl-glucosamine thiazoline

Treatment of adult Tay-Sachs disease

N-acetyl-procainamide

Prevention of life-threatening ventricular arrhythmias in patients with documented procainamide-induced lupus.

N-acetylcysteinate Lysine

Nacystelyn Dry Powder Inhaler

For the management of cystic fibrosis

Galephar Pharmaceutical Research, Inc.

Treatment of acute liver failure

Cumberland Pharmaceuticals, Inc.



N-acetylcysteine n/a 7/19/2012 Edward A. Neuwelt, MD

n/a 8/31/2015 Edward A. Neuwelt, MD

Naglazyme 2/17/1999

n/a 10/16/2007 Sequella, Inc.

n/a 7/18/2013 Verastem, Inc.

Prevention of ototoxicity caused by platinum-based chemotherapeutic agents used to treat pediatric cancers

N-acetylcysteine and sodium thiosulfate

Prevention of platinum-induced toxicities in pediatric patients (0 through 16 years of age).

N-acetylgalactosamine-4-sulfatase, recombinant human

Treatment of mucopolysaccharidosis Type VI (Maroteaux-Lamy syndrome).

BioMarin Pharmaceutical, Inc.

N-adamantanyl-N'-Geranyl-ethylenediamine


N-methyl-4-({4-[({3-methyl(methylsulfonyl)amino]pyrazin-2-yl}methyl)amino]-5-(trifluoromethyl)pyrimidin-2-yl}amino)benzamide hydrochloride

Treatment of mesothelioma



n/a 5/12/2015 Andrew Lim

n/a 3/21/2013 sanofi-aventis U.S. LLC

n/a 5/18/2009

n/a 2/4/2011 Sequella, Inc.

n/a 8/7/2014 Sun BioPharma, Inc.

N-t-butylhydroxylamine

Treatment of infantile neuronal ceroid lipofuscinosis.

N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate

Treatment of polycythemia vera

N-tert-butyl-3-[5-methyl-2-{[4-(2-pryyolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl-amino] benzenesulfonamide dihydrochloride monohydrate

Treatment of secondary and primary myelofibrosis

Sanofi-Aventis US, LLC a Sanofi company

N-{[(5S)-3-(3-fluoro-4-thiomorpholin-4-ylphenyl)-2-oxo-1,3-oxazolidin-5-yl]methyl}acetamide


N1,N14,-diethyl-3,12,-dihydroxyhomospermine




n/a 2/27/2008

n/a 12/7/2000

NDX-peptides n/a 12/14/2010

Nafarelin acetate 7/20/1988 Syntex (USA), Inc.

N2'-Deacetyl-N2'-[4-methyl-4-(oxobuthyldithio)-1-oxopentyl]-maytansine-chimerized anti-CD138 IgG4 Monoclonal Antibody



N2'-deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maystansine-Conjugated Humanized C242 Monoclonal Antibody

For pancreatic cancer



NeoDiagnostic Research Ltd

Synarel Nasal Solution

Treatment of central precocious puberty.



Naltrexone HCl Trexan 3/11/1985 DuPont Pharmaceuticals

NanoDTPA(tm) n/a 6/17/2011 Nanotherapeutics, Inc.

n/a 8/10/2000 Amarillo Biosciences, Inc.


For blockade of the pharmacological effects of exogenously administered opioids as an adjunct to the maintenance of the opioid-free state in detoxified formerly opioid-dependent individuals.

Treatment of known or suspected cases of internal contamination with plutonium, americium, or curium

Natural human lymphoblastoid interferon-alpha

Treatment of papillomavirus warts in the oral cavity of HIV positive patients.

Natural human lymphoblastoid interferon-alpha




Nebacumab Centoxin 10/1/1986 Centocor, Inc.

Neurotrophin-1 n/a 9/13/1994

Cylexin 12/22/1993 Cytel Corporation

Nifedipine n/a 6/13/1991

Nikkomycin Z n/a 2/14/2006

Nimotuzumab n/a 11/17/2004 InnoKeys PTE Ltd.

Treatment of patients with gram-negative bacteremia which has progressed to endotoxin shock.

Treatment of motor neuron disease/amyotrophic lateral sclerosis.

Ericsson, Arthur Dale, M.D.

Neutrophil-endothelial interaction inhibitor

Treatment of post-ischemic pulmonary reperfusion edema following surgical treatment for chronic thromboembolic pulmonary hypertension.

Treatment of interstitial cystitis.

Fleischmann, Jonathan M.D.

Treatment of coccidioidomycosis

Valley Fever Center for Excellence (1-111 INF)

Treatment of glioma



n/a 9/3/2004 The Vaccine Company



Nitazoxanide Alinia 12/12/1996 Romark Laboratories, L.C.

Nitisinone Orfadin 10/19/2001 Swedish Orphan AB

Nitisinone Orfadin 5/16/1995

Nitric oxide n/a 2/16/2005

Nitric oxide n/a 9/11/2013 Novoteris, LLC

Nitric oxide Inomax 9/27/2004 INO Therapeutics

Nitric oxide Inomax 6/22/1993 INO Therapeutics, Inc.

Nine amino acid polypeptide derived from proteinase 3



Treatment of myelodysplastic syndromes requiring therapy



Treatment of cryptosporidiosis.

Treatment of alkaptonuria

Treatment of tyrosinemia type 1.

Swedish Orphan Biovitrum AB (PUBL)

Diagnosis of sarcoidosis

SensorMedics Corporation


To reduce the risk of chronic lung disease in premature neonates

Treatment of persistent pulmonary hypertension in the newborn.



Nitric oxide n/a 7/10/1995 INO Therapeutics, Inc.

Nitroprusside n/a 2/21/2001

n/a 12/31/2013 US Biotest, Inc.


n/a 9/10/2009 Antisoma, Inc.

n/a 8/17/2004 Antisoma Research Ltd.

n/a 7/28/2005 Antisoma Inc.

Treatment of acute respiratory distress syndrome in adults.

Treatment and prevention of cerebral vasospasm following subarachnoid hemorrhage.

Thomas, MD, Jeffrey Evan

NorLeu3-Angiontensin(1-7)) [NorLeu3-A(1-7)]

Treatment of leakage from the surgical site following penetrating keratoplasty

NorLeu3-Angiotensin(1-7) [NorLeu3-A(1-7)]

Treatment of dermal injury due to nuclear/radiation incident

Nucleic acid aptamer binding to tumor cell nucleolin


Nucleic acid aptamer binding to tumor cell nucleolin


Nucleic acid aptamer binding to tumor cell nucleon




n/a 1/15/2013

n/a 3/16/2012 JSK Therapeutics, Inc.

n/a 12/13/2013 JSK Therapeutics, Inc.

n/a 12/23/2014

Octreotide Sandostatin Lar 8/24/1998

O-(3-piperidino-2-hydroxyl-1-propyl)-nicotinic acid amidoxime hydrochloride


N-Gene Research Laboratories, Inc.

O2-(2,4-dinitrophenyl) 1-[(4-ethoxycarbonyl)piperazin-1-yl]diazen-1-ium-1,2-diolate


O2-(2,4-dinitrophenyl) 1-[(4-ethoxycarbonyl)piperazin-1yl]diazen-1-ium-1,2-diolate


OTL38; conjugate of pteroi acid and S0456 near infrared dye

Detecting folic receptor alpha positive lesions in ovarian cancer patients (diagnostic for the management of ovarian cancer)

On Target Laboratories, LLC

Treatment of acromegaly.






Ofloxacin 4/18/1991 Allergan, Inc.

n/a 11/22/1995

Omacor 5/4/2000 Pronova Biocare, AS

Omegaven 2/27/2008

Treatment of diarrhea associated with vasoactive intestinal peptide tumors (VIPoma).


Treatment of severe diarrhea and flushing associated with malignant carcinoid tumors.


Ocuflox Ophthalmic Solution

Treatment of bacterial corneal ulcers.

Omega-3 (n-3) polyunsaturated fatty acid with all double bonds in the cis configuration

Prevention of organ graft rejection.

Research Triangle Pharmaceuticals

Omega-3 (n-3) polyunsaturated fatty acids

Treatment of IgA nephropathy.

Omegaven emulsion

Treatment of parenteral nutrition-associated liver disease

Fresenius Kabi Deutschland GmbH




Oprelvekin Neumega 12/17/1996 Genetics Institute, Inc.

Oxaliplatin n/a 10/6/1992 Debio Pharm S.A.

Oxaloacetic acid n/a 11/18/2015 Terra Biological LLC

n/a 3/29/2006 OxThera, Inc.

Oxandrolone Oxandrin 9/6/1991

Oxandrolone Oxandrin 4/22/1997

Oncolytic adenovirus coding for granulocyte macrophage colony stimulating factor (ONCOS-102)


Prevention of severe chemotherapy-induced thrombocytopenia.



Oxalobacter formigenes

Treatment of primary hyperoxaluria

Adjunctive therapy for AIDS patients suffering from HIV-wasting syndrome.

Bio-Technology General Corp.

Treatment of patients with Duchenne's muscular dystrophy and Becker's muscular dystrophy.

Savient Pharmaceuticals, Inc.



Oxymorphone 3/19/1985

Oxypurinol n/a 11/9/1998 Cardiome Pharma Corp.

n/a 1/9/2013 Lentigen Corporation

n/a 4/2/2015 Co-D Therapeutics, Inc.

Lysodase 12/9/1992

Numorphan H.P.

For relief of severe intractable pain in narcotic-tolerant patients.

DuPont Merck Pharmaceutical Company

Treatment of hyperuricemia in patients intolerant to allopurinol.

P140K MGMT transduced human CD34 cells

For bone marrow protection in the treatment of glioblastoma multiforme

PEG-b-PLA micelles containing (1) paclitaxel, (2) sirolimus (rapamycin) and (3) tanespimycin (17-AAG)(also known as: triolimus)

Treatment of angiosarcoma

PEG-glucocerebrosidase

For use as chronic enzyme replacement therapy in patients with Gaucher's disease who are deficient in glucocerebrosidase.

National Institute of Mental Health, NIH



PEG-interleukin-2 n/a 2/1/1990 Chiron Corporation

n/a 10/25/2013

n/a 10/1/2014

n/a 7/5/2012 PhytoHealth Corporation

n/a 12/27/2012 PharmaIN Corporation

Paclitaxel Paxene 4/15/1997

Paclitaxel Taxol 3/25/1997

Treatment of primary immunodeficiencies associated with T-cell defects.

PEGylated recombinant anti-Pseudomonas aeruginosa PcrV Fab' antibody

Treatment of cystic fibrosis patients with Pseudomonas aeruginosa lung infections

KaloBios Pharmaceuticals, Inc.

PEGylated recombinant human hyaluronidase PH20


Halozyme Therapeutics, Inc.

PG2 (Astragalus polysaccharides extracted and purified from the dry root of Astragalus membranaceus)


PGC-C12E-terlipressin

Treatment of ascites due to all etiologies except for cancer


Baker Norton Pharmaceuticals, Inc.





n/a 5/14/2007

n/a 8/31/2007

Wobe-Mugos 12/21/1998

Medi-491 5/7/1999 MedImmune, Inc.

Adagen 5/29/1984

Pegaspargase Oncaspar 10/20/1989

Pegfilgrastim Neulasta 11/20/2013 Amgen, Inc.

Pafuramidine maleate


Immtech Pharmaceuticsl, Inc.

Pafuramidine maleate

Treatment of human African trypanosomiasis (sleeping sickness)


Papain, trypsin, and chymotrypsin


Marlyn Nutraceuticals, Inc.

Parvovirus B19 (recombinant VP1 and VP2; S.frugiperda cells) vaccine

Prevention of transient aplastic crisis in patients with sickle cell anemia.

Pegademase bovine

For enzyme replacement therapy for ADA deficiency in patients with severe combined immunodeficiency.

Sigma-tau Pharmaceuticals, Inc.

Treatment of acute lymphocytic leukemia.

Sigma-tau Pharmaceuticals, Inc.

Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident



Pegasys 7/13/1998 Hoffman-La Roche Inc.

Pegasys 9/30/1999 Hoffman-La Roche Inc.

Pegvisomant Somavert 6/24/1997 Sensus Corporation

Melanocid 4/12/1999

Peldesine n/a 10/5/1993

n/a 10/29/1984 Aventis Behring L.L.C.

Pentam 300 2/28/1984 Fujisawa USA, Inc.

Nebupent 1/12/1988 Fujisawa USA, Inc.

Peginterferon alfa-2a


Peginterferon alfa-2a


Treatment of acromegaly.

Pegylated arginine deiminase

Treatment of invasive malignant melanoma.

Polaris Pharmaceuticals, Inc.


BioCryst Pharmaceuticals, Inc.

Pentamidine isethionate

Treatment of Pneumocystis carinii pneumonia.


Treatment of Pneumocystis carinii pneumonia.


Prevention of Pneumocystis carinii pneumonia in patients at high risk of developing this disease.



Pneumopent 10/5/1987 Fisons Corporation

Cylexin 7/18/1997 Cytel Corporation

Pentastarch Pentaspan 8/28/1985 DuPont Pharmaceuticals

Pentamidine isethionate (inhalation)

Prevention of Pneumocystis carinii pneumonia in patients at high risk of developing this disease

Pentasaccharide ethyl glycoside consisting of one alpha-D-sialylosyl residue as a sodium salt, two beta-D-galactopyranosyl residues, one 2-acetamido-beta-D-glucopyranosyl unit, and one alpha-L-fucopyranosyl unit

Treatment of neonates and infants undergoing cardiopulmonary bypass during surgical repair of congenital heart lesions.

As an adjunct in leukapheresis to improve the harvesting and increase the yield of leukocytes by centrifugal means.



Elmiron 8/7/1985 Alza Corporation

Pentostatin Nipent 11/24/1999 SuperGen, Inc.



Nipent 9/10/1987 SuperGen, Inc.

n/a 4/27/2006 Digna Biotech, S.L.

n/a 4/26/2006 Digna Biotech, S.L.

n/a 9/15/2010 Rose Pharmaceuticals

n/a 5/14/2007 Aeterna Zentaris GmbH

Perflubron Liquivent(Tm) 4/26/2001

Pentosan polysulfate sodium

Treatment of interstitial cystitis.

Treatment of peripheral T-cell lymphomas.


Treatment of patients with chronic lymphocytic leukemia.

Pentostatin for injection

Treatment of hairy cell leukemia.

Peptide 144 TGF beta-1 inhibitor


Peptide 144 TGF beta-1-inhibitor

Treatment of localized scleroderma

Peptide that inhibits mechanosensitive ion channel (MSC) activity

Treatment of Duchenne Muscular Dystrophy (DMD.)

Peptidomimetic analog of hexarelin

Diagnosis of growth hormone deficiency

Treatment of acute respiratory distress disease (ARDS) in adults

PFC Development/New Alliance Pharmaceutical



Phenylacetate n/a 3/6/1998 Elan Drug Delivery, Inc.

3/8/1995 BioMarin Pharmaceutical

Phenylbutyrate n/a 1/19/2000 Elan Drug Delivery, Inc.

n/a 11/2/2010

Picoplatin n/a 11/2/2005 Poniard Pharmaceuticals

Pilocarpine Salagen 9/24/1990 MGI Pharma, Inc.

For use as an adjunct to surgery, radiation therapy and chemotherapy for the treatment of patients with primary or recurrent malignant glioma.

Phenylalanine ammonia-lyase

Phenylase. Ravpal-Peg

Treatment of hyperphenylalaninemia


Phosphatidylinositol 3-Kinase "PI3K" Inhibitor

Treatment of chronic lymphocytic leukemia (CLL)

Semafore Pharmaceuticals


Treatment of xerostomia induced by radiation therapy for head and neck cancer.



Pilocarpine HCl Salagen 2/28/1992 MGI Pharma, Inc.

n/a 3/29/2005

Plitidepsin Aplidin 9/30/2004 PharmaMar USA, Inc.

Poloxamer 188 Florcor 2/22/1990 CytRx Corporation

Poloxamer 188 n/a 8/5/1997 CytRx Corporation

Poloxamer 331 Protox 3/21/1991 CytRx Corporation

Treatment of xerostomia and keratoconjunctivitis sicca in Sjogren's syndrome patients.

Plasmid DNA vector expressing cystic fibrosis transmembrane gene


Copernicus Therapeutics, Inc.


Treatment of severe burns requiring hospitalization.

Treatment of vasospasm in subarachnoid hemorrhage patients following surgical repair of a ruptured cerebral aneurysm.

Initial therapy of toxoplasmosis in patients with AIDS.



Poly I: poly C12U Ampligen 12/9/1993



Poly-ICLC Hiltonol 3/17/1997 Oncovir

Zurase 12/21/1998 EnzymeRx, LLC

n/a 6/6/2005 EnzymeRx, LLC

Treatment of invasive metastatic melanoma (stage IIb, III, IV).

Hemispherx Biopharma, Inc.

Treatment of chronic fatigue syndrome.




Treatment of primary brain tumors.

Polyethylene glycol-modified uricase

Treatment of tumor lysis syndrome in cancer patients undergoing chemotherapy.


Treatment of hyperuricemia in patients with gout refractory to conventional therapy or in whom conventional therapy is contraindicated



Zurase 9/14/1999 EnzymeRx, LLC

Polymeric oxygen n/a 3/25/1992 Capmed USA

Ampligen 7/19/1988

n/a 6/9/2006 Polynoma LLC

N-Graft 6/24/1997


Prophylaxis of hyperuricemia in cancer patients prone to develop tumor lysis syndrome during chemotherapy.

Treatment of sickle cell anemia.

Polyribonucleotide; Polyribo-inosinic/-cyclidylic/-uridylic acid

Treatment of AIDS.


Polyvalent, shed-antigen melanoma vaccine

Treatment of stage IIb to stage IV melanoma

Porcine Sertoli cells aseptically prepared for intracerebral co-implantation with fetal neural tissue

Treatment of Hoehn and Yahr stage four and five Parkinson's disease.

Titan Pharmaceuticals, Inc.



Neurocell-Pd 12/17/1996 Diacrin/Genzyme LLC

Neurocell-Pd 12/17/1996 Diacrin/Genzyme LLC

Neurocell-Hd 12/10/1996 Diacrin/Genzyme LLC

Porcine fetal neural dopaminergic cells and/or precursors aseptically prepared and coated with anti-MHC-1 Ab for intracerebral implantation

Treatment of Hoehn and Yahr stage 4 and 5 Parkinson's disease.

Porcine fetal neural dopaminergic cells and/or precursors aseptically prepared for intracerebral implantation.

Treatment of Hoehn and Yahr stage 4 and 5 Parkinson's disease.

Porcine fetal neural gabaergic cells and/or precursors aseptically prepared and coated with anti-MHC-1 Ab for intracerebral implantation




Neurocell-Hd 12/10/1996 Diacrin/Genzyme LLC

Porfimer sodium Photofrin 6/6/1989



Porfiromycin Promycin 9/19/1995

Porcine fetal neural gabaergic cells and/or precursors aseptically prepared for intracerebral implantation for Huntington's disease.


For the photodynamic therapy of patients with primary or recurrent obstructing (either partially or completely) esophageal carcinoma.

QLT Phototherapeutics, Inc.

Treatment of cholangiocarcinoma

Concordia Laboratories, Inc.

For the photodynamic therapy of patients with transitional cell carcinoma in situ of the urinary bladder.

QLT Phototherapeutics, Inc.

Treatment of head and neck cancer.

Boehringer Ingelheim Pharmaceuticals, Inc.



Porfiromycin Promycin 3/13/1997

Posaconazole Posoril 7/16/2004

Thyroshield 11/17/2004

Potassium citrate Urocit-K 11/1/1984

Potassium citrate Urocit-K 11/1/1984

Treatment of cervical cancer.


Treatment of zygomycosis

Schering-Plough Corporation

Potassium Iodide Oral Solution

For use as a thyroid blocking agent in pediatric patients exposed to radiactive iodine

Fleming & Company, Pharmaceuticals

Prevention of uric acid nephrolithiasis.

University of Texas Health Science Center at Dallas

1. Prevention of calcium renal stones in patients with hypocitraturia 2. For avoidance of the complication of calcium stone formation in patients with uric lithiasis.

University of Texas Health Science Center at Dallas



n/a 7/23/1993 Sanofi Winthrop, Inc.

Procarbazine HCl Matulane 8/8/2006

Circulase 6/12/1998 LTT Baio-Pharma Co., Ltd

Protaxel n/a 5/21/2003 Biophysica, Inc.

Ceprotin 6/23/1992 Baxalta US, Inc.

Primaquine phosphate

For use in combination with clindamycin hydrochloride in the treatment of Pneumocystis carinii pneumonia associated with AIDS.



Prostaglandin E1 enol ester (AS-013)

Treatment of Fontaine Stage IV chronic critical limb ischemia.


Protein C concentrate

For replacement therapy in congenital protein C deficiency for the prevention and treatment of thrombosis, pulmonary emboli, and purpura fulminans.



6/19/1992

Curosurf 8/2/1993 Chiesi USA, Inc.

Immudyn 9/22/1997 Able Laboratories, Inc.

Colloral 2/9/1995 AutoImmune, Inc.

Protein C concentrate

Protein C Concentrate (Human) Vapor Heated, Immuno

For replacement therapy in patients with congenital or acquired protein C deficiency for the prevention and treatment of warfarin-induced skin necrosis during oral anticoagulation.

Immuno Clinical Research Corp.

Pulmonary surfactant replacement, porcine

For the treatment and prevention of respiratory distress syndrome in premature infants.

Purified extract of Pseudomonas aeruginosa

Treatment of immune thrombocytopenia purpura where it is required to increase platelet counts.

Purified type II collagen




Imt504 11/24/2014

Pyruvate n/a 2/21/2001 Cellular Sciences, Inc

R-(-)-gossypol n/a 10/24/2006

n/a 9/10/2009 Trio Medicines Ltd.

n/a 11/28/2008

REMUNE HIV 1 n/a 2/14/2014

PyNTTTTGT class of oligodeoxynucleotide with a 24-base single chain composed of nucleotide sequence 5'TCATCATTTTGTCATTTTGTCATT 3'

Treatment of rabies virus infections

Mid-Atlantic BioTherapeutics, Inc.

Treatment of interstitial lung disease.

Treatment of chronic lymphocytic leukemia.

Ascenta Therapeutics, Inc.

R-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1 H -1,4-benzodiazepine -3-yl]-3-(3-methylaminophenyl)urea

Treatment of gastric carcinoids

R-4-amino-3-(4-chlorophenyl)butanoic acid

Treatment of the behavorial abnormalities associated with fragile X syndrome

Seaside Therapeutics, Inc.

Treatment of pediatric HIV/AIDS (age through 16 years)

Immune Response BioPharma, Inc.



RII retinamide n/a 5/6/1993

Thymoglobulin 9/26/2006

Rapamycin n/a 3/20/2007 OncoImmune, Inc.

n/a 2/6/2014 Andarix Pharmaceuticals

n/a 6/19/2014

n/a 4/30/2014 Abeona Therapeutics LLC


Sparta Pharmaceuticals, Inc.

Rabbit anti-human thymocyte globulin (rATG)

Induction treatment to prevent rejection and to minimize maintenance immunosupression in pediatric liver transplant recipients

Children's Hospital of Pittsburgh

Treatment of tuberous sclerosis complex

Re188 P2045 somatostatin analog


Re188 P2045 somatostatin peptide analogue


Andarix Pharmaceuticals, Inc.

Recombinant AAV9 expressing human alpha-N-acetylglucosaminidase

Mucopolysaccharidosis III-B (Sanfilippo Syndrome Type B)



n/a 8/18/2005 Henogen S.A.

n/a 7/24/2012 Apogenix GmbH

n/a 2/22/2001


n/a 10/4/2005 Zymo Genetics, Inc

n/a 3/22/2010 SuppreMol GmbH

Recombinant Epstein-Barr virus gp350 glycoprotein vaccine

Prevention of post-transplantation lymphoproliferative disorders in pediatric recipients of solid-organ transplantation

Recombinant Fusion Protein

Treatment of Myelodysplastic Syndrome

Recombinant Human Alpha-Fetoprotein (rhAFP)

Treatment of myasthenia gravis

Alpha Cancer Technologies, Inc.

Recombinant Human Factor VIIa Variant

Routine prophylaxis to prevent bleeding episodes in patients with hemophilia A and B patients with inhibitors

Recombinant Human Interleukin-21 (rIL-21)

Treatment of stage II (T4), III or IV malignant melanoma.

Recombinant Human soluble Fc-gamma Receptor IIb




n/a 3/29/2006 Y's Therapeutics, Inc.

n/a 7/26/2007 Y's Therapeutics, Inc.

n/a 5/2/2003

n/a 5/11/2009

Recombinant P-Selectin glycoprotein ligand

Prevention of delayed graft function in renal transplant patients

Recombinant P-selectin glycoprotein ligand-immunoglobulin Ig

Prevention of ischemia reperfusion injury in all solid organ transplants

Recombinant T-cell receptor ligand

Treatment of multiple sclerosis patients who are both HLA-DR2 positive and autoreactive to myelin oligodendrocyte glycoprotein residues 35-55

Artielle ImmunoTherapeutics, Inc.

Recombinant adeno-associated virus (serotype 2) (rAAV2) gene transfer agent expressing RPE65

Treatment of Leber's congential amaurosis

AmpliPhi Biosciences Corporation



n/a 6/24/2008 Spark Therapeutics, Inc.

n/a 8/20/2009 Affimed Therapeutics AG

n/a 4/26/2006 PharmaOrigin ApS

n/a 7/29/2008

Recombinant adeno-associated virus retinal pigment epithelium gene vector AAV2-hRPE65v2

Treatment of Leber congenital amaurosis due to RPE65 mutations.

Recombinant antibody construct against human CD30 and CD16A


Recombinant coagulation factor VIIa

Treatment of diffuse alveolar hemorrhage

Recombinant disintegrin and metalloprotease with thrombospondin type 1 motifs

Treatment of thrombotic thrombocytopenic purpura including its congential, acquired idiopathic, and secondary forms.




n/a 7/29/2008

Valortim 2/16/2006 PharmAthene, Inc.

n/a 3/19/2001

n/a 10/13/2009 Apogenix GmbH

n/a 6/9/2006

Recombinant disintegrin and metalloprotease with thrombospondin type 1 motifs

Prevention of thrombotic thrombocytopenic purpura including its congential, acquired idiopathic and secondary forms.


Recombinant fully human monoclonal antibody to anthrax protective antigen

Treatment of anthrax infection

Recombinant fusion protein of Mycobacterium bovis BCG Hsp65 and HPV16 E7

Treatment of recurrent respiratory papillomatosis (RRP)

StressGen Biotechnologies, Inc. is now Nventa

Recombinant fusion protein-extracellular portion of CD95 fused to the Fc part of human IgG1


Recombinant human C1 inhibitor

Treatment of capillary leakage syndrome

Pharming Technologies B.V.



n/a 6/9/2006 Pharming Group N.V.

n/a 2/23/1999 Pharming Group N.V.


n/a 7/13/1998

8/19/1997 Genzyme Corporation

Recombinant human C1 inhibitor

Prevention and/or treatment of delayed graft function after solid organ transplantation

Recombinant human C1-esterase inhibitor

Prophylactic treatment of angioedema caused by hereditary or acquired C1-esterase inhibitor deficiency.

Recombinant human CD4 immunoglobulin G

Treatment of AIDS resulting from infection with HIV-1.

Recombinant human Clara Cell 10kDa protein

Prevention of neonatal bronchopulmonary dysplasia in premature neonates with respiratory distress syndrome.

Therabron Therapeutics, Inc.

Recombinant human acid alpha-glucosidase; alglucosidase alfa

1. Myozyme 2. Lumizyme

Treatment of glycogen storage disease type II.



n/a 4/28/2005

n/a 2/2/2006 Zymenex A/S

n/a 4/6/2000 AT III LLC


n/a 10/4/2007

n/a 3/6/1995

n/a 1/12/1994

Recombinant human alpha 1-antitrypsin

Prevention of bronchopulmonary dysplasia

Arriva Pharmaceuticals, Inc.

Recombinant human alpha-mannosidase

Treatment of alpha-mannosidosis

Recombinant human antithrombin III

Treatment of antithrombin III dependent heparin resistance requiring anticoagulation.

Recombinant human endostatin protein


Recombinant human fibrinogen

Treatment of bleeding in patients deficient in fibrinogen

Pharming Technologies B.V.

Recombinant human gelsolin

Treatment of acute and chronic respiratory symptoms of bronchiectasis.

BioAgeis, Therapeutics, Inc.

Recombinant human gelsolin

Treatment of the respiratory symptoms of cystic fibrosis.

BioAegis Therapeutics, Inc.



n/a 3/22/2010 Diamyd Therapeutics AB

n/a 7/24/2006 Nora Therapeutics, Inc.

Tbd 9/20/2000

n/a 4/11/2001

Recombinant human glutamic acid decarboxylase 65KDa isoform

Treatment of Type I diabetes with residual beta cell function

Recombinant human granulocyte colony stimulating factor

Prevention of implantation failure and unexplained recurrent miscarriage

Recombinant human highly phosphorylated acid alpha-glucosidase

For enzyme replacement therapy in patients with all subtypes of glycogen storage disease type II (GSDII, Pompe Disease)

Novazyme Pharmaceuticals, Inc.

Recombinant human highly phosphorylated alpha-L-iduronidase (rhHP-IDUA)

Enzyme replacement therapy in patients with all subtypes of Mucopolysaccharidosis I.

Novazyme Pharmaceuticals, Inc.



Pv802 2/16/2000 GroPep Pty Ltd.

n/a 6/15/1999 Insmed, Inc.

n/a 10/20/1997 Genetics Institute, Inc.

n/a 12/20/1999

Recombinant human insulin-like growth factor-I

Treatment of short-bowel syndrome as a result of resection of the small bowel or as a result of congenital dysfunction of the intestines.

Recombinant human insulin-like growth factor-I/insulin-like growth factor binding protein-3

Treatment of major burns that require hospitalization.

Recombinant human interleukin-12


Recombinant human keratinocyte growth factor

Reducing the incidence and severity of radiation-induced xerostomia.




Luveris 10/7/1994 EMD Serono, Inc.

Cholestrase 7/14/2005

n/a 1/23/2006 ThromboGenics Ltd


n/a 2/1/2007

Recombinant human luteinizing hormone

For use in association with recombinant human follicle stimulating hormone for the treatment of women with chronic anovulation due to hypogonadotropic hypogonadism.

Recombinant human lysosomal acid lipase or cholesteryl ester hydrolase

Treatment of lipase deficiencies, including Wolman Disease and cholesteryl ester storage disease

Lysosomal Acid Lipase, LLC

Recombinant human microplasmin

Treatment of peripheral arterial occlusion

Recombinant human nerve growth factor

Treatment of HIV-associated sensory neuropathy.

Recombinant human platelet derived growth factor BB

Treatment of osteonecrosis of the jaws

Luitpold Pharmaceuticals, Inc.









Recombinant human thrombopoietin

For use in accelerating platelet recovery in patients undergoing hematopoietic stem cell transplantation.

Recombinant humanized MAb 5c8

Prevention of rejection of pancreatic islet cell transplants.


Prevention and treatment of Factor VIII/Factor IX inhibitors in patients with hemophilia A or B.


Prevention of rejection of solid organ transplants.

Recombinant humanized anti-LOXL2 monoclonal antibody


Recombinant humanized monclonal antibody 5c8





n/a 2/11/2002

n/a 2/11/2002

n/a 11/28/1994 Amgen, Inc.

Recombinant humanized monoclonal antibody 5c8

Treatment of systemic lupus erythematosus.

Recombinant immunotoxin combining the functional components of antibody against mesothelin and the enzymatic activity of a pseudomonas exotoxin


National Institutes of Health

Recombinant immunotoxin combining the functional components of antibody against mesothelin and the enzymatic activity of a pseudomonas exotoxin

Treatment of epithelial ovarian cancer


Recombinant methionyl brain-derived neurotrophic factor




n/a 4/12/1999 Schering Corporation


n/a 3/29/1991 Amgen, Inc.


n/a 6/24/2005 Aerovance, Inc.

n/a 10/11/2000

Cachexon 2/14/1994

Recombinant replication deficient adenovirus vector carrying human p53 gene

Treatment of primary ovarian cancer.

Recombinant retroviral vector - glucocerebrosidase

For use as enzyme replacement therapy for patients with types I, II, or III Gaucher disease.

Recombinant secretory leucocyte protease inhibitor


Recombinant soluble human CD4 (rCD4)

Treatment of AIDS in patients infected with HIV virus.

Recombinant truncated SPINT2 protease inhibitor


Recombinant urate oxidase

Prophylaxis of chemotherapy-induced hyperuricemia.

Sanofi-Synthelabo Research

Reduced L-glutathione

Treatment of AIDS-associated cachexia.

Telluride Pharmaceutical Corporation



Advexin 1/27/2003



Gvax Pancreas 3/1/2010 Aduro BioTech, Inc.

Replication defective recombinant adenovirus serotype 5 vector carrying the p53 gene in its E1 deleted region

Treatment of head and neck cancer

Introgen Therapeutics, Inc.

Replication-incompetent GM-CSF-expressing gene-modified allogeneic acute myeloid leukemia cancer cell lines

Gvax Acute Myeloid Leukemia


Replication-incompetent GM-CSF-expressing gene-modified allogeneic chronic myeloid leukemia cancer cell lines

Gvax Chronic Myeloid Leukemia


Replication-incompetent GM-CSF-expressing gene-modified allogeneic pancreatic cancer cell lines




9/27/1990 MedImmune, Inc.

Respigam 9/27/1990

n/a 3/26/2010 DesignMedix

Revimmune n/a 2/18/2011

Reviparin sodium Clivarine 6/18/2001 Abbott

Respiratory Syncytial Virus Immune Globulin (human)

Hypermune Rsv

Treatment of respiratory syncytial virus lower respiratory tract infections in hospitalized infants and young children.

Respiratory syncytial virus immune globulin (Human)

Prophylaxis of respiratory syncytial virus lower respiratory tract infections in infants and young children at high risk of RSV disease.

MedImmune & Massachussetts Public Health Biologics Labs.

Reversal agent linked to chloroquine-like moiety


Treatment of autoimmune hemolytic anemia.

Accentia Biopharmaceuticals

Treatment of deep vein thrombosis which may lead to pulmonary embolism in pediatric patients



Reviparin sodium Clivarine 6/18/2001 Abbott

Winrho Sd 11/9/1993 Rh Pharmaceuticals, Inc.

Rifabutin Mycobutin 12/18/1989 Adria Laboratories, Inc.

Rifabutin n/a 12/18/1989 Pfizer Inc.

Rifalazil n/a 4/13/1999

Long-term treatment of acute deep vein trombosis with or without pulmonary embolism in pregnant patients

Rho (D) immune globulin intravenous (human)


Prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infection.

Treatment of disseminated Mycobacterium avium complex disease.


PathoGenesis Corporation



Rifampin Rifadin I.V. 12/9/1985 Hoechst Marion Roussel

Rifater 9/12/1985 Hoechst Marion Roussel

Rifapentine Priftin 6/9/1995 Hoechst Marion Roussel

Rifapentine Priftin 6/9/1995

Rifapentine Priftin 3/12/1996

Rilonacept Arcalyst 12/20/2004

Riluzole Rilutek 10/15/1996

For antituberculosis treatment where use of the oral form of the drug is not feasible.

Rifampin, isoniazid, pyrazinamide

For the short-course treatment of tuberculosis.


Treatment of Mycobacterium avium complex in patients with AIDS.

Hoechst Marion Roussel , Inc.

Prophylactic treatment of Mycobacterium avium complex in patients with AIDS and a CD4+ count less than or equal to 75/mm3.

Hoechst Marion Roussel, Inc.

Treatment of CIAS1-Associated Periodic Syndromes

Regeneron Pharmaceuticals, Inc.


Rhone-Poulenc Rorer Pharmaceuticals, Inc.



Riluzole Rilutek 3/16/1993

n/a 12/21/2006

Rosburix 8/4/2014 4D Pharma Research Ltd

n/a 3/14/2002 EntreMed Incorporated

2/14/2011 Cerus Corporation

n/a 10/20/2009 MBiotec GmBH

n/a 4/30/1998 Genopia USA, Inc.



Rose Bengal Disodium

Treatment of metastatic melanoma

Provectus Pharmaceuticals, Inc.

Roseburia hominis

Treatment of ulcerative colitis in pediatric patients age 0 through 16 years

S(-)-3-[3-amino-phthalimido]-glutaramide


S-59 treated FFP (plasma treated with amotosalen hydrochloride & ultraviolet A light

Intercept Blood System For


S-[2,3-bispalmitoyloxy-(2R)-propyl]-cysteinly-GNNDESNISFKEK


S-adenosylmethionine

Treatment of AIDS-myelopathy.



n/a 5/12/2009

n/a 12/28/2012 Salupont Consulting Ltd

n/a 11/16/2015

S-nitrosoglutathione

Management of cystic fibrosis patients to improve airway clearance and to improve or stabilize pulmonary function

N30 PHARMAceuticals, LLC

S-nitrosoglutathione

Treatment of severe preeclampsia

S3,S13-cyclo(D-tyrolsyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-aspartyl-L-tryptophyl-N-methyl-L-glycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-N-methyl-L-isoleucinamide

Treatment of C3 glomerulopathy.

Amyndas Pharmaceuticals



n/a 10/9/2014

n/a 11/12/2003 Patrys Limited

n/a 7/7/2005

Sacrosidase Sucraid 12/10/1993 QOL Medical, LLC

Homspera 3/16/2011

S3,S13-cyclo(D-tyrolsyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-aspartyl-L-tryptophyl-N-methyl-L-glycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-N-methyl-L-isoleucinamide)

Treatment of paroxysmal nocturnal hemoglobinuria (PNH)

Amyndas Pharmaceuticals

SC-1 monoclonal antibody

Treatment of patients with CD55 (sc-1) positive gastric tumors

SDF-1 (108) Lysine Dlmer

Treatment of osteogenic sarcoma

Chemokine Therapeutics Corporation

Treatment of congenital sucrase-isomaltase deficiency

Sar9, Met(O2)11-Substance P


ImmuneRegen BioSciences, Inc.



Sargramostim Leukine 3/6/1995 Immunex Corporation

Sargramostim Leukine 5/3/1990 Immunex Corporation

9/25/1989 Cytogen Corporation

Secalciferol Osteo-D 7/26/1993

n/a 6/30/1992 Synergen, Inc.

To reduce neutropenia and leukopenia and decrease the incidence of death due to infection in patients with acute myelogenous leukemia.

Treatment of neutropenia associated with bone marrow transplant, for the treatment of graft failure and delay of engraftment, and for the promotion of early engraftment.

Satumomab pendetide

Oncoscint Cr/Ov

Detection of ovarian carcinoma.

Treatment of familial hypophosphatemic rickets.


Secretory leukocyte protease inhibitor

Treatment of bronchopulmonary dysplasia.



n/a 6/4/1996

Selegiline HCl Eldepryl 11/7/1984

n/a 5/14/2014

n/a 8/22/2008 Neotropix, Inc.

Selective inhibitor of polymorphonuclear leukocyte (PMN) elastase

Therapeutic management of patients with lung disease attributable to cystic fibrosis.

DuPont Pharmaceuticals Company

As an adjuvant to levodopa and carbidopa treatment of idiopathic Parkinson's disease (paralysis agitans), postencephalitic Parkinsonism, and symptomatic Parkinsonism.

Somerset Pharmaceuticals, Inc.

Selinexor; (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N-(pyrazin-2-yl)acrylohydrazide



Seneca Valley virus




Geref 9/14/1988 EMD Serono, Inc.

Imuvert 9/7/1988 Cell Technology, Inc.

Colomed 8/19/1997 Richard I. Breuer, M.D.

Colomed 5/29/1990 Richard I. Breuer

Legalon Sil 2/17/2012 Meda AB

Flammacerium 11/17/1999

Siponimod n/a 11/26/2013

Sermorelin acetate

Treatment of idiopathic or organic growth hormone deficiency in children with growth failure.

Serratia marcescens extract (polyribosomes)


Short chain fatty acid enema

Treatment of chronic radiation proctitis.

Short chain fatty acid solution

Treatment of the active phase of ulcerative colitis with involvement restricted to the left side of the colon.

Silibinin-C-2',3-dihydrogensuccinate, disodium salt

Prevention of recurrent hepatitis C in liver transplant patients

Silver sulfadiazine and cerium nitrate

Treatment of patients with severe dermal burns

Sinclair Pharmaceuticals Ltd

Treatment of polymyositis




n/a 11/2/2004

Borocell 4/15/1992

n/a 2/16/2012

n/a 3/4/2005

Sitaxsentan Sodium

For the treatment of pulmonary arterial hypertension in the absence of chronic obstructive pulmonary disease or congestive heart failure.

Pfizer Global Research and Development

Sodium Monomercaptoundecahydro-closo-dodecaborate

For use in boron neutron capture therapy (BNCT) in the treatment of glioblastoma multiforme.

Neutron Technology Corp.& Neutron R&D Partner

Sodium Thiosulfate

Treatment of uremic and non-uremic calciphylaxis


Sodium aluminosilicate

Treatment of chronic hepatic encephalopathy

Framework Therapeutics, LLc



Apatone 7/31/2007 IC-MedTech Corporation

n/a 11/10/1994

n/a 6/11/1990

n/a 6/11/1990

Sodium nitrite n/a 1/17/2007 Hope Pharmaceuticals


Sodium ascorbate and menadione sodium bisulfite

Treatment of metastatic or locally advanced inoperable transitional cell carcinoma of the urothelium (stage III and IV bladder cancer)

Sodium dichloroacetate

Treatment of lactic acidosis in patients with severe malaria.

Stacpoole, Peter W. M.D., Ph.D.


Treatment of homozygous familial hypercholesterolemia.



Treatment of congenital lactic acidosis


Prevention of vasospasm associated with subarachnoid hemorrhage





3/23/2007

Ammonul(R) 6/3/2005 Ucyclyd Pharma, Inc.

n/a 3/20/2007 Tikvah Therapeutics, Inc.

Buphenyl 1/25/2007 OrphaMed, Inc.

n/a 4/24/1998 Elan Drug Delivery, Inc.

Sodium pyruvate n/a 3/31/2003 Cellular Sciences, Inc

Treatment of vaso-occlusive crisis associated with sickle cell disease

Sodium nitrite/sodium thiosulfate

Cyanide Antidote Package


Keystone Pharmaceuticals, Inc.

Sodium phenylacetate/sodium benzoate 10%/10% Injection

Treatment of grade III and IV hepatic encephalopathy

Sodium phenylbutyrate





For use as an adjuct to surgery, radiation therapy and chemotherapy for the treatment of patients with primary or recurrent malignant glioma.




n/a 6/16/2006

Sotradecol 6/10/1986 Elkins-Sinn, Inc.

n/a 3/17/2004

n/a 12/18/2006 Akorn, Inc.

6/16/2006

Coramsine 2/6/2006

Coramsine 11/2/2005

n/a 3/6/2000

Sodium stibogluconate

Treatment of cutaneous leishmaniasis

VioQuest Pharmaceuticals, Inc.

Sodium tetradecyl sulfate

Treatment of bleeding esophageal varices.

Sodium thiosulfate

Prevention of platinum-induced ototoxicity in pediatric patients

Fennec Pharmaceuticals, Inc.

Sodium thiosulfate and sodium nitrite


Sodium thiosulfate, sodium nitrite, amyl nitrite

Cyanide Antidote Package


Keystone Pharmaceuticals, Inc.

Solasonine and solamargine

Treaatment of high risk stage II, stage III and stage IV melanoma

Solbec Pharmaceuticals Limited

Solasonine and solamargine


Solbec Pharmaceuticals Limited

Soluble complement receptor type 1

Prevention of post-cardiopulmonary bypass syndrome in children undergoing cardiopulmonary bypass.

Avant Immunotherapeutics, Inc.



n/a 11/21/1994 T Cell Sciences, Inc.

Somatostatin n/a 12/22/1994

Somatostatin Zecnil 6/20/1988 Ferring Laboratories, Inc.

Soluble recombinant human complement receptor type 1

Prevention or reduction of adult respiratory distress syndrome.


Eumedica Pharmaceuticals A.G. (Schweiz)

Adjunct to the non-operative management of secreting cutaneous fistulas of the stomach, duodenum, small intestine (jejunum and ileum), or pancreas.



Protropin 12/9/1985 Genentech, Inc.

Somatropin Serostim 3/16/2004 EMD Serono, Inc.

Somatropin Nutropin 3/6/1987 Genentech, Inc.

Somatrem for injection

1. Long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion (prevalence 15,000) 2. Treatment of short stature associated with Turner's syndrome (prevalence 8000).

Treatment of patients with HIV-associated adipose redistribution syndrome

For use in the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.



Somatropin Humatrope 5/8/1990 Eli Lilly and Company

Somatropin Genotropin 9/6/1994 Pharmacia & Upjohn

Somatropin Norditropin 8/9/2006 Novo Nordisk Inc.

Somatropin Humatrope 12/15/2005 Eli Lilly and Company

Saizen 5/3/1989 EMD Serono, Inc.

Zorbtive 3/6/1995 EMD Serono, Inc.

Treatment of short stature associated with Turner syndrome.

Treatment of adults with growth hormone deficiency.

Treatment of short stature in patients with Noonan syndrome

Treatment of short stature in pediatric patients with short stature homeobox-containing gene (SHOX) deficiency

Somatropin (rDNA)

For the enhancement of nitrogen retention in hospitalized patients suffering from severe burns.

Somatropin (r-DNA)

For use alone or in combination with glutamine in the treatment of short bowel syndrome.



Serostim 3/26/1996 EMD Serono, Inc.

Saizen 3/6/1987 EMD Serono, Inc.

10/28/1999 Genentech, Inc.

Somatropin (r-DNA) for injection

Treatment of children with AIDS-associated failure-to-thrive including AIDS-associated wasting.

Somatropin (rDNA origin)

Treatment of idiopathic or organic growth hormone deficiency in children with growth failure.

Somatropin (rDNA origin)

Nutropin Depot

Long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.



Norditropin 7/10/1987

Genotropin 7/6/1999 Pharmacia & Upjohn

Serostim 11/15/1991 EMD Serono, Inc.

Nutropin 8/4/1989 Genentech, Inc.


Somatropin (rDNA origin) injection

1. Treatment of growth failure in children due to inadequate growth hormone secretion 2. Treatment of short stature associated with Turner's syndrome

Novo Nordisk Pharmaceuticals

Somatropin [rDNA]

Treatment of short stature in patients with Prader-Willi syndrome.

Somatropin for injection

Treatment of AIDS-associated catabolism/weight loss.


Treatment of growth retardation associated with chronic renal failure.


As replacement therapy for growth hormone deficiency in adults after epiphyseal closure.




Humatrope 6/12/1986 Eli Lilly and Company

Sorafenib Nexavar 10/8/2004

Sorafenib Nexavar 4/20/2006

Sotalol HCl Betapace 9/23/1988 Berlex Laboratories, Inc.


Treatment of short stature associated with Turner's syndrome.


For the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone.


Bayer Pharmaceutical Corporation


Bayer Pharmaceuticals Corporation

1. Treatment of life-threatening ventricular tachyarrhythmias 2. Prevention of life treatening ventricular tachyarrhythmias



Altastaph 1/29/2004

Accusol 5/29/2009

Sterile talc Steritalc 12/8/1997 Novatech SA

Sterile talc Steritalc 12/8/1997 Novatech SA

9/18/1995 Bryan Corporation

Succimer Chemet 11/5/1990 Sanofi Winthrop, Inc.

Staphylococcus aureus Immune Globulin (Human)

Prophylaxis against Staphylococcus aureus infections in low birth weight neonates


Sterile Bicarbonate Infusate, Hemofiltration, Hemodiafiltration, and Hemopdialysis Solution

For use as a replacement solution in adults and children during Continous Renal Replacement Therapy


Treatment of pneumothorax.


Sterile talc powder

Sclerosol Intrapleural Aerosol


Prevention of cystine kidney stone formation in patients with homozygous cystinuria who are prone to stone development.



Succimer 5/9/1984

Succimer Chemet 3/22/1991 Sanofi Winthrop, Inc.

n/a 3/4/1991

n/a 3/12/1990

Sulfadiazine n/a 3/14/1994

Sulfapyridine n/a 9/10/1990

Chemet Capsules

Treatment of lead poisoning in children.

Bock Pharmacal Company

Treatment of mercury intoxication.

Sucralfate suspension

Treatment of oral ulcerations and dysphagia in patients with epidermolysis bullosa.

Darby Pharmaceuticals, Inc.

Sucralfate suspension

Treatment of oral complications of chemotherapy in bone marrow transplant patients.

Darby Pharmaceuticals, Inc.

For use in combination with pyrimethamine for the treatment of Toxoplasma gondii encephalitis in patients with and without AIDS.

Eon Labs Manufacturing, Inc.

Treatment of dermatitis herpetiformis.




n/a 3/6/1985

Suramin Metaret 5/6/1997

Synsorb Pk n/a 7/17/1995 Synsorb Biotech Inc.

n/a 3/31/2015 MYR GmbH

Superoxide dismutase (human)

For protection of donor organ tissue from damage or injury mediated by oxygen-derived free radicals that are generated during the necessary periods of ischemia (hypoxia, anoxia), and especially reperfusion, associated with the operative procedure.

Pharmacia-Chiron Partnership

Treatment of hormone-refractory prostate cancer.


Treatment of verocytotoxogenic E. coli infections.

Synthetic 47 amino acid-long N-terminally myristoylated, HBV-L-protein derived lipopeptide

Treatment of hepatitis D virus infection.



Drepanol 10/24/1991 Omex International, Inc.

n/a 9/25/2012

n/a 9/18/2006

n/a 6/16/1999 ChiRhoClin, Inc.

Synthetic derivative of 16-hydroxy-9Z, 12Z, 14E-octadecatrienoic acid

Prophylactic treatment of sickle cell disease.

Synthetic double-stranded siRNA oligonucleotide against caspase 2 mRNA

Treatment of ischemic optic neuropathy

Quark Pharmaceuticals, Inc.

Synthetic human secretin

For use in conjunction with diagnostic procedures (excluding ERCP) for pancreatic disorders to increase pancreatic fluid secretion

Innovate Biopharmaceuticals, Inc.


For use in obtaining desquamated pancreatic cells for cytopathologic examination in pancreatic carcinoma.



Chirostim 6/16/1999 ChiRhoClin, Inc.



Secreflo 6/18/1999 ChiRhoClin, Inc.


For use in the diagnosis of gastrinoma associated with Zollinger-Ellison syndrome.


For use in the evaluation of exocrine pancreas function.


For use in conjunction with diagnostic, therapeutic, or combined diagnostic/therapeutic procedures for pancreatic disorders to increase pancreatic fluid secretion.

Synthetic porcine secretin

For use in the diagnosis of gastrinoma associated with Zollinger-Ellison syndrome.






Neurovax 2/6/2014


For use in conjunction with diagnostic, therapeutic, or combined diagnostic/therapeutic procedures for pancreatic disorders to increase pancreatic fluid secretion.


For use in the evaluation of exocrine pancreas function.


For use in obtaining desquamated pancreatic cells for cytopathologic examination in pancreatic carcinoma.

T cell receptor (TCR) peptide (BV5S2, BV6S5, BV13S1) vaccine

Treatment of Pediatric Multiple Sclerosis

Immune Response BioPharma, Inc.



n/a 11/1/2001 Nexell Therapeutics Inc.

n/a 6/27/1989 AGI Dermatics

TD-K6a.513a.12 Reveker 6/15/2006 TransDerm, Inc.

TXA127 n/a 10/25/2013 US Biotest, Inc.

Tacrolimus Prograf 4/6/1998 Fujisawa USA, Inc.

Tacrolimus Prograf 6/6/2005 Astellas Pharma US, Inc.

Taliglucerase alfa 9/3/2009 Pfizer, Inc.

T-cell depleted stem cell enriched cellular product from peripheal b lood stem cells

Treatment of chronic granulomatous disease

T4 endonuclease V, liposome encapsulated

To prevent cutaneous neoplasms and other skin abnormalities in xeroderma pigmentosum.

Treatment of pachyonychia congenita

Treament of acute radiation syndrome

Prophylaxis of graft-versus-host-disease.

Prophylaxis of organ rejection in patients receiving heart transplants.

Elelyso For Injection

Treatment of Gaucher's disease



Tamibarotene n/a 10/11/2007 CytRx Corporation

Tanespimycin n/a 9/9/2004 Bristol-Myers Squibb

n/a 5/14/2014 Tyg Oncology Ltd

Lymphoscan 4/7/1992 Immunomedics, Inc.

Treatment of acute promyelocytic leukemia (APL).


Targeted Gastrin 17 Complexed Peptide


Technetium Tc99m murine monoclonal antibody (IgG2a) to B cell

Diagnostic imaging in the evaluation of the extent of disease in patients with histologically confirmed diagnosis of non-Hodgkin's B-cell lymphoma, acute B-cell lymphoblastic leukemia (in children and adults), and chronic B-cell lymphocytic leukemia.



Apomate 11/3/2000

3/17/2009 Pharmalucence, Inc.

n/a 7/20/2006 Taiho Pharma USA, Inc.

Temoporfin Foscan 10/28/1999

Temozolomide Temodal 10/18/2004

Technetium Tc99m rh-Annexin V

Diagnosis or assessment of rejection status in heart, heart-lung, single lung, or bilateral lung transplants.

Theseus Imaging Corporation

Technetium Tc99m sulfur colloid injection, lyophilized

Technetium Tc99m Sulfur Colloi

For localization of sentinel lymph nodes in patients with melanoma.

Tegafur/gimeracil/oteracil


Palliative treatment of recurrent, refractory or second primary squamous cell carcinomas of the head and neck in patients considered to be incurable with surgery or radiotherapy.

Biolitec Pharma Ireland Ltd.

Treatment of newly diagnosed high grade glioma

Schering-Plough Research Institute



Temozolomide Temodal 10/14/1998

Temsirolimus Torisel 12/16/2004

Teniposide 11/1/1984

Teriparatide Parathar 1/9/1987

Teriparatide Parathar 10/28/1999 Biomeasure, Inc.

Terlipressin Glypressin 3/6/1986 Ferring Laboratories, Inc.

Treatment of advanced metastatic melanoma.




Vumon For Injection

Treatment of refractory childhood acute lymphocytic leukemia.


Diagnostic agent to assist in establishing the diagnosis in patients presenting with clinical and laboratory evidence of hypocalcemia due to either hypoparathyroidism or pseudohypoparathyroidism.


Treatment of idiopathic osteoporosis.




Testosterone 9/22/1997 Watson Laboratories

n/a 7/31/1991 Star Pharmaceuticals, Inc.

Tetrabenazine Xenazine 12/11/1997

Tetrabenazine n/a 5/12/1998

n/a 5/1/2000 Danforth, Jr., MD, Elliot

Tezacitabine n/a 1/27/2003 Sanofi-Aventis US, Inc.

Theraderm Testosterone Transdermal System

For use as physiologic testosterone replacement in androgen deficient HIV+ patients with an associated weight loss.

Testosterone propionate ointment 2%

Treatment of vulvar dystrophies.


Prestwick Pharmaceuticals, Inc

Treatment of moderate/severe tardive dyskinesia.

Prestwick Pharmaceuticals, Inc.

Tetraiodothyroacetic acid

Suppression of thyroid stimulating hormone in patients with well-differentiated cancer of the thyroid gland.

Treatment of adenocarcinoma of the esophagus and stomach



Thalidomide n/a 1/12/1993 Celgene Corporation

Thalidomide Synovir 3/11/1996 Celgene Corporation

Thalidomide n/a 3/5/1990



Thalidomide Thalomid 7/26/1995 Celgene Corporation



Treatment of the clinical manifestations of mycobacterial infection caused by Mycobacterium tuberculosis and non-tuberculous mycobacteria.

Treatment of HIV-associated wasting syndrome.

Prevention of graft versus host disease.

Andrulis Research Corporation

Treatment of graft versus host disease.


Treatment and maintenance of reactional lepromatous leprosy.

Pediatric Pharmaceuticals, Inc.

Treatment of erythema nodosum leprosum.

Treatment of Crohn's disease.









Treatment and prevention of recurrent aphthous ulcers in severely, terminally immunocompromised patients.


Treatment of Kaposi's sarcoma.

Treatment of severe recurrent aphthous stomatitis in severely, terminally immunocompromised patients.





n/a 10/23/2008 Aldagen, Inc.

n/a 10/1/2014

n/a 1/26/2015

Thiotepa Tepadina 4/2/2007 Adienne S.A.

Thawed donor matched banked umbilical cord blood enriched by cell sorting to produce a subpopulation expressing high levels of intracellular aldehyde dehydrogenase

To improve patient outcomes by decreasing time to platlet and neutrophil engraftment in patients with inherited metabolic diseases (IMD) undergoing umbilical cord blood transplantation.

Theranost 68 Ga RGD

A Diagnostic for the management of Moyamoya disease (MMD)

Advanced Imaging Projects, LLC (AIP)

Theranost 68Ga RGD

Diagnostic for the clinical management of patients with tuberculosis


Conditioning treatment prior to hematopoietic stem cell transplantation



Thymalfasin Zadaxin 3/13/2006




Thymosin beta 4 n/a 5/28/2004

Thyrotropin alfa Thyrogen 8/3/2001 Genzyme Corporation

Thyrotropin alpha Thyrogen 2/24/1992 Genzyme Corporation

n/a 12/27/2000

Treatment of stage IIb through Stage IV malignant melanoma

SciClone Pharmaceuticals, Inc.

Treatment of chronic active hepatitis B.




Treatment of DiGeorge anomaly with immune defects.


Treatment of epidermolysis bullosa.

RegeneRx Biopharmaceuticals, Inc.

Treatment of well-differentiated papillary, follicular or combined papillary/follicular carcinomas of the thyroid

As an adjunct in the diagnosis of thyroid cancer.

Tiazofurin (2-Beta-D-ribofuranosyl-4-thiazolecarboxamide)

Chronic myelogenous leukemia (CML)

Valeant Pharmaceuticals North America



n/a 4/11/2005

Tinidazole Tindamax 8/20/2003 Presutti Laboratories, Inc.

Tiopronin Thiola 1/17/1986 Pak, Charles Y.C. M.D.

Spiriva 1/8/2008

Tipifarnib Zarnestra 7/6/2004

Tilarginine acetate

Treatment of cardiogenic shock

Arginox Pharmceuticals, Inc.

Treatment of amebiasis

Prevention of cystine nephrolithiasis in patients with homozygous cystinuria.

Tiotropium bromide

To improve pulmonary function in conjunction with standard therapy in the management of patients with cystic fibrosis



Johnson & Johnson Pharmaceutical Research & Dev.



Tiratricol Triacana 8/13/1991 Laphal Laboratoires

n/a 4/18/2011

n/a 3/13/2006 Aastrom Biosciences, Inc.

For use in combination with levo-thyroxine to suppress thyroid stimulating hormone in patients with well-differentiated thyroid cancer who are intolerant to adequate doses of levo-thyroxine alone.

Tissue Plasminogen activator

Treatment of acute ischemic stroke (AIS) in children age 16 years and younger.

Catherine Amlie-Lefond, MD

Tissue repair cells obtained from autologous bone marrow expanded ex vivo with a cell production system

Treatment of osteonecrosis.



n/a 1/25/2007 Vericel Corporation.

Tizanidine HCl Zanaflex 1/31/1994

Tobramycin Tobi 6/18/1999

Tobi 10/13/1994

Tolcapone n/a 12/24/2013

Topiramate Topamax 11/25/1992

Toremifene n/a 8/17/1993 Orion Corporation

Tissue repair cells obtained from autologous bone marrow expanded ex vivo with a cell production system

Treatment of dilated cardiomyopathy

Treatment of spasticity associated with multiple sclerosis and spinal cord injury.

Athena Neurosciences, Inc.

Treatment of bronchiectasis patients infected with Pseudomonas aeruginosa.


Tobramycin for inhalation

Treatment of bronchopulmonary infections of Pseudomonas aeruginosa in cystic fibrosis patients.

Novartis Pharmaceuticals Corp

Treatment of transthyretin amyloidosis

SOM Innovation Biotech SL (SOM Biotech)


Johnson & Johnson Pharmaceutical R & D, LLC

Treatment of desmoid tumors.



Toremifene Fareston 9/19/1991 Orion Corporation

Tosedostat n/a 12/10/2008

Bexxar 5/16/1994 GlaxoSmithKline LLC

n/a 4/26/2005

n/a 1/28/2005

Tranilast Rizaben 12/2/2003

n/a 12/18/1992

n/a 5/19/1999

Treosulfan Ovastat 5/16/1994 Medac GmbH

Hormonal therapy of metastatic carcinoma of the breast.


CTI BioPharma Corporation

Tositumomab and iodine I 131 tositumomab

Treatment of non-Hodgkin's B-cell lymphoma.

Tramadol hydrochloride



Tramadol hydrochloride



For the treatment of maligant glioma

Angiogen Pharmaceuticals, Pty. Ltd.

Transforming growth factor-beta 2

Treatment of full thickness macular holes.

Celtrix Pharmaceuticals, Inc.

Transgenic human alpha 1 antitrypsin

Treatment of emphysema secondary to alpha 1 antitrypsin deficiency.

PPL Therapeutics (Scotland) Limited




Tretinoin Atra-Iv 4/11/2003 Antigenics, Inc.

Tretinoin Atra-Iv 1/14/1993 Antigenics, Inc.

Tretinoin n/a 4/15/1985

Tretinoin Vesanoid 10/24/1990 Hoffmann-La Roche, Inc.

Trientine HCl Syprine 12/24/1984


Treatment of acute and chronic leukemia.

Treatment of squamous metaplasia of the ocular surface epithelia (conjunctiva and/or cornea) with mucous deficiency and keratinization.

Hannan Ophthalmic Marketing Services, Inc


Treatment of patients with Wilson's disease who are intolerant, or inadequately responsive to penicillamine.

Merck Sharp & Dohme Research



Triheptanoin 2/1/2008 Baylor Research Institute

Triheptanoin 5/26/2006 Baylor Research Institute

Neutrexin 5/15/1986

Biosynject 4/20/1987 Chembiomed, Ltd.


Triheptanoin-Sasol Special Oil

Treatment of glycogen storage disorder II (Pompe disease)

Triheptanoim-Sasol Special Oil

Treatment of fatty acid disorders

Trimetrexate glucuronate

Treatment of Pneumocystis carinii pneumonia in AIDS patients.


Trisaccharides A and B

For use in ABO-incompatible solid organ transplantation, including kidney, heart, liver and pancreas.


Prevention of ABO medical hemolytic reactions arising from ABO-incompatible bone marrow transplantation.




Hemocitrate 6/15/1995

n/a 2/27/2004 CustomCare Pharmacy

Trypan blue Membraneblue 8/2/2006


Treatment of moderate to severe clinical forms of hemolytic disease of the newborn arising from placental transfer of antibodies against blood group substances A and B.

Trisodium citrate concentration

For use in leukapheresis procedures.

Hemotec Medical Products, Inc.

Trisodium zinc Diethylenetriaminepentaacetate

Treatment of patients with known or suspected internal contamination with plutonium, americium, or curium to increase the rate of elimination.

Selectively staining epiretinal membranes during ophthalmic surgical vitrectomy procedures

Dutch Ophthalmic Research Center Int'l BV





Tyloxapol Supervent 3/8/1995 Kennedy & Hoidal, M.D.'s

n/a 2/1/2008

Ubi-Q-Nol 4/12/2004

Ubiquinone Ubi-Q-Gel 12/14/1999

n/a 3/22/2001

Tumor necrosis factor-binding protein 1

Treatment of symptomatic patients with AIDS including all patients with CD4 counts less than 200 cells per mm3.

Tumor necrosis factor-binding protein II

Treatment of symptomatic patients with the AIDS including all patients with CD4 T-cell counts less than 200 cells per mm3.


Type 1 native bovine skin collagen

Treatment of diffuse systemic sclerosis

arGentis Pharmaceuticals, LLC

Ubiquinol, coenzyme Q10, ubiquinone

Treatment of pediatric congestive heart failure

Gel-Tec, Division of Tishcon Corporation

Treatment of mitochondrial cytopathies.

Gel-Tec, Division of Tishcon Corp.

Unconjugated Chimeric (human-murine) G250 IgG monoclonal antibody


Wilex Biotechnology GmbH



Neurosolve 12/14/2005

Urofollitropin Metrodin 11/25/1987 EMD Serono, Inc.

Urogastrone n/a 11/1/1984 Chiron Vision

Ursodiol Urso 250 6/20/1991 Aptalis Pharma US, Inc.

Cnj-016 6/18/2004 Cangene Corporation

Urea for intravitreal injection


Vitreo Retinal Techologies, Inc

For induction of ovulation in patients with polycystic ovarian disease who have an elevated LH/FSH ratio and who have failed to respond to adequate clomiphene citrate therapy.

For acceleration of corneal epithelial regeneration and healing of stromal incisions from corneal transplant surgery.

Treatment of patients with primary biliary cirrhosis

Vaccinia Immune Globulin (Human) Intravenous

Treatment of complications of vaccinia vaccination



n/a 6/18/2004

Vil 1/5/1996 Leas Research Products

Valproate n/a 5/5/2008 Neuropharm Ltd,

Valrubicin Valstar 5/23/1994

Vapreotide Sanvar 4/6/2004 H3 Pharma, Inc.

Varbulin Azixa 11/5/2009 Myrexis, Inc.

Varizig 11/7/2006 Cangene bioPharma, Inc.

Varlitinib n/a 8/5/2015 ASLAN Pharmaceuticals

Vaccinia Immune Globulin (Human) Intravenous

Treatment of severe complications from the smallpox vaccine

DynPort Vaccine Company LLC

Valine, isoleucine and leucine



Treatment of carcinoma in situ of the urinary bladder.

Anthra Pharmaceuticals, Inc.

Treatment of symptomatic carcinoid tumors


Varicella Zoster Immune Globulin (Human)

Passive immunization for the treatment of exposed, susceptible individuals who are at risk of complications from varicella

Treatment of cholangiocarcinoma.



n/a 3/9/2001 mondoBIOTECH

n/a 6/23/1993

Vasomera n/a 11/19/2015

Virulizin Virulizin 2/1/2001 ZOR Pharmaceuticals, LLC

3/26/2010 Fox Pharma, Inc.

11/27/1998 Circe Biomedical, Inc.

Vasoactive intestinal peptide

Treatment of Acute Respiratory Distress Syndrome.

Vasoactive intestinal polypeptide

Treatment of acute esophageal food impaction.

Research Triangle Pharmaceuticals

Treatment of cardiomyopathy associated with dystrophinopathies; Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy BMD), and X-linked dilated cardiomyopathy (XL-dCMP).

PhaseBio Pharmaceuticals, Inc.


Water-miscible vitamin A palmitate

Aquasol A Parenteral

Prevention of bronchopulmonary dysplasia.

Xenogeneic hepatocytes

Hepatassist Liver Assist System

Treatment of severe liver failure.



Ferritarg P 9/18/2006 Alissa Pharma, LLC

n/a 12/3/2012


Zalcitabine n/a 12/9/1986

Zalcitabine Hivid 6/28/1988 Hoffmann-La Roche, Inc.

Zinc acetate Galzin 11/6/1985 Lemmon Company

Zoledronate Zometa, Zabel 8/18/2000

n/a 12/15/2005

Yttrium (90Y) antiferritin polyclonal antibodies

Treatment of Hodgkin's disease.

Yttrium(90Y)-DTPA-radiolabelled chimeric monoclonal antibody against frizzled homologue 10


OncoTherapy Science, Inc.

Yttrium-90 radiolabeled humanized monoclonal anti-carcinoembroyonic antigen IgG antibody

Treatment of ovarian carcinoma.

Treatment of AIDS.

National Cancer Institute, DCT

Treatment of AIDS.


Treatment of tumor induced hypercalcemia.


Zosuquidar trihydrochloride


Kanisa Pharmaceuticals, Inc.



n/a 9/17/2008

n/a 11/4/2003

n/a 2/14/2014 Plexxikon, Inc.

n/a 10/20/2014 Synovo GmbH

n/a 1/12/2011 Tocagen, Inc.

[131I]-N-(2-(diethylamino) ethyl-4-(4 flurobenzamido)-5-(iodo)-2-methoxybenzamide

Treatment of metastatic melanoma, stages IIB, IIC, III and IV

Molecular Insight Pharmaceuticals, Inc. (Progenics Subsidiary)

[5,10,15,20-tetrakis(1,3-diethylimidazolium-2-yl)porphyrinato] manganese(III)pentachloride


Aeolus Pharmaceuticals, Inc.

[5-(5-Chloro-1H-pyrrolo[2,3-b]pyridin-3-ylmethyl)-pyridin-2-yl]-(6-trifluoromethyl-pyridin-3-ylmethyl)-amine hydrochloride salt

Treatment of pigmented villonodular synovitis/giant cell tumor of the tendon sheath

[5-Amino-1-(4-fluoro-phenyl)-1H-pyrazol-4-yl]-[3-(2,3-dihydroxy-propoxy)-phenyl]-methanone


[AC3-yCD2(V)] and Flucytosine (5-FC XR)




n/a 1/12/2009

n/a 5/14/2014 Angiochem, Inc.

1/24/2013 TNI BioTech, Inc.

n/a 4/15/2015 Angiochem, Inc.

n/a 4/29/2014 Advaxis, Inc.

[Lu-177]-DOTA-Tyr3-Octreotate

Treatment of gastro-entero-pancreatic neuroendocrine tumors

Advanced Accelerator Applications

[a-N-(2'succinyl-paclitaxel)Thr]-Phe-Phe-Tyr-Gly-Gly-Ser-Arg-Gly-[epsilon-N-(2'succinyl-paclitaxel)Lys]-Arg-Asn-Asn-Phe-[epsilon-N-(2'succinyl-paclitaxel)Lys]-Thr-Glu-Glu-Tyr


[met5]-enkephalin

Opioid Growth Factor


[Î±â¿¿N-(2â¿¿succinyl-paclitaxel)Thr]-Phe-Phe-Tyr-Gly-Gly-Ser-Arg-Gly-[Îµâ¿¿N-(2â¿¿succinyl-paclitaxel)Lys]-Arg-Asn-Asn-Phe-[Îµâ¿¿N-(2â¿¿succinyl-paclitaxel)Lys]-Thr-Glu-Glu-Tyr

Treatment of breast cancer patients with brain metastases

a live attenuated bioengineered Listeria monocytogenes cancer immunotherapy

Treatment of Stage II to IV invasive cervical carcinoma



a-Galactosidase A 1/21/2003 iBio, Inc.

n/a 9/12/2013 Sparks Therapeutics, Inc.

abatacept Orencia 5/30/2013 Orban Biotech LLC

n/a 4/18/2011 Cortice Biosciences

n/a 10/7/2011 Cortice Biosciences

acadesine n/a 5/4/2011

acadesine n/a 3/3/2011

acamprosate n/a 3/25/2013

Plant-Produced Human A-Glactosidase A

Treatment of Fabry's disease

aadeno-associated viral vector, serotype 2, containing the human choroideremia gene encoding human Rab escort protein 1

Treatment of choroideremia due to mutations in the human choroideremia gene (CHM)

Treatment of type 1 diabetes mellitus patients with residual beta cell function

abeotaxane inhibitor of microtubules

Treatment of pediatric neuroblastoma.

abeotaxane inhibitor of microtubules



Advancell-Advanced In Vitro Cell Technologies S.A.


Avanced In Vitro Cell Technologies, S.L.


Confluence Pharmaceuticals, LLC



n/a 11/24/2015 Genus Oncology, LLC

acetyl-l-carnitine n/a 7/24/2012

n/a 3/18/2011

acetylcysteine Acetadote 10/19/2001

n/a 2/24/2015

acetyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-cysteinyl-D-glutaminyl-D-cystenyl-D-arginyl-D-arginyl-D-lysyl-D-asparaginylmaide disulfide


Treatment of Fragile X syndrome


acetyl-l-carnitine (ALC)



For the intravenous treatment of moderate to severe acetaminophen overdose

Cumberland Pharmaceuticals, Inc.

acetylcysteine effervescent tablets for oral solution

Preventing hepatic injury from acetaminophin overdose

Arbor Pharmaceuticals, LLC



acyclovir n/a 12/13/2010 Fera Pharmaceuticals

adalimumab Humira 5/13/2014 AbbVie, Inc.


adalimumab n/a 7/10/2014 Mucora


adalimumab Humira 3/21/2005 AbbVie Inc.

Treatment of acute herpetic keratitis caused by Herpes Simplex Virus type 1 and 2

Treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis

Treatment of moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease)


Treatment of pediatric Crohn's disease.

Treatment of juvenile rheumatoid arthritis




n/a 9/29/2015 REGENXBIO, Inc.

n/a 3/17/2011 Fondazione Telethon

n/a 5/6/2013 Lysogene

n/a 3/14/2014

Treatment of pediatric patients with ulcerative colitis

aden-associated virus vector serotype 9 expressing human a-L-iduronidase

Treatment of mucopolysaccharidosis Type I (MSP I).

adeno associated viral vector containing human ARSB gene

Treatment of mucopolysaccharidosis type VI (MPS VI; Maroteaux-Lamy syndrome)

adeno associated viral vector serotype rh.10 carrying the human SGSH and SUMF1 cDNAs

Treatment of mucopolysaccharidosis type IIIA (Sanfilippo type A syndrome)

adeno associated virus with modified transthyretin and sequence encoding factor IX variant gene

Treatment of hemophilia B




n/a 11/18/2015 LYSOGENE


n/a 12/13/2012

adeno-associated viral (AAV) vector serotype rh. 10 encoding the human N-sulfoglycosamine sulphohydrolase cDNA (SGSH)

Treatment of mucopolysaccharidosis type IIIA or Sanfilippo type A syndrome

adeno-associated viral vector composed of a bioengineered AAV capsid and a codon-optimized expression cassette encoding a high-specific activity variant of human coagulation factor IX


adeno-associated viral vector containing DNA encoding an RNAi targeting rhodopsin in combination with an adeno-associated viral vector containing DNA encoding a rhodopsin gene

treatment of retinitis pigmentosa

Genable Technologies Limited



n/a 9/15/2010 uniQure B.V.

n/a 11/20/2013 Gen Sight Biologics

n/a 5/21/2007

n/a 11/5/2014 NightstaRx Ltd.

n/a 12/27/2012

adeno-associated viral vector containing modified U11 snRNA


adeno-associated viral vector containing the human NADH Dehydrogenase 4 Gene

Treatment of Leber Hereditary Optic Neuropathy

adeno-associated viral vector expressing human retinoschisin-1 gene

Treatment of X-linked juvenile retinoschisis (XLRS).


adeno-associated viral vector serotype 2 containing the human Rab escort protein 1 gene

Treatment of choroideremia

adeno-associated viral vector serotype 9 containing human N-acetylglucosaminidase alpha gene

Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome)

Laboratorios del Dr. Esteve, S.A.



Calmarythm 10/2/2014 Cardiogen Sciences, Inc.


n/a 9/30/2014 AveXis, Inc.

n/a 7/16/2015

n/a 11/19/2012 Milo Biotechnology

adeno-associated viral vector serotype 9 containing the human cardiac calsequestrin gene

Treatment of catecholaminergic polymorphic ventricular tachycardia

adeno-associated viral vector type 2 expressing human recombinant retinal pigment epithelial 65KDa protein gene

Treatment of Retinitis Pigmentosa due to autosomal recessive RPE65 gene mutations

adeno-associated virus serotype 9 expressing the human Survival Motor Neuron gene


adeno-associated virus serotype 9 vector containing human Iduronate-2-sulfatase transgene

Treatment of mucopolysaccharidosis type II (Hunter syndrome).


adeno-associated virus transgene of follistatin

Treatment of Duchennes and Becker's muscular dystrophy



n/a 11/16/2015

n/a 6/1/2011

n/a 6/8/2015 PNP Therapeutics, Inc.

n/a 4/2/2012 Vascular Biogenics Ltd

adeno-associated virus type 8 delivering a vector genome with human retinoschisin promoter (RS/IRBP) and the human retinoschisin cDNA (hRS)

Treatment of X-linked retinoschisis

Paul A. Sievig, MD, PhD, National Eye Institute, NIH

adeno-associated virus vector serotype 9 expressing human sulfamidase

Treatment of mucopolysaccharidosis type IIIA (Sanfilippo A Syndrome).


adenoviral vector expressing the E.coli purine nucleoside phosphorylase gene and fludarabine

Intratumoral treatment of anatomically accessible oral and pharyngeal cancers (lip, tongue, gum, floor of mouth, salivary gland, and other oral cavity)

adenovirus containing a human FAS-c gene




n/a 10/1/2014 DNAtrix, Inc.

n/a 7/14/2015 MTG Biotherapeutics

Multistem 7/6/2012 Athersys, Inc.

n/a 5/27/2015 HemoGenyx LLC

n/a 3/11/2013 Beena G. Sood, MD, MS

afamelanotide n/a 5/14/2014 Clinuvel, Inc.

afamelanotide n/a 12/11/2009 Clinuvel, Inc.

afamelanotide n/a 7/17/2008 Clinuvel Inc.

adenovirus delta 24-RGD, an oncolytic adenovirus genetically modified for treatment of glioma

Treatment of glioma

adenovirus vaccine encoding reduced expression in immortalized cell protein


adult adherent bone marrow-derived multipotent stem cells

Treatment of MPS-1, including Hurler syndrome

adult hemogenic endothelial cells

Treatment of aplastic anemia

aerosolized beractant

Treatment of respiratory distress syndrome

Treatment of familial benign chronic pemphigus (Hailey-Hailey disease)

Treatment of solar urticaria

Treatment of erythropoietic porphyrias



afatinib Gilotrif 12/3/2012

afatinib Gilotrif(R) 6/4/2014

afatinib Gilotrif(R) 8/3/2015

aldoxorubicin n/a 9/24/2014 CytRx Corporation



alectinib n/a 1/27/2015 Genentech, Inc.

alemtuzumab Campath 10/20/1997 Genzyme Corporation

Treatment of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).


Treatment of malignant brain and central nervous system tumors


Treatment of non-small cell lung cancer with squamous histology.

Boehringer Ingelheim Pharmaceuticals, INc.




Treatment of ALK-positive non-small cell lung cancer




alfimeprase n/a 9/20/2012 Niche Therapeutics, LLC

algenpantucel-L 10/21/2010

alicaforsen n/a 6/24/2008

alisertib n/a 5/14/2012

alisertib n/a 7/12/2013

Retriacyl 5/21/2014 Natac Pharma, S.L.

allantoin Alwextin 11/21/2002 Scioderm, Inc.

n/a 4/21/2015 Capricor, Inc.

Treatment of ST-elevation myocardial infarcted patients who are undergoing primary percutaneous coronary intervention

Hyperacute(R)-Pancreatic Cance


NewLink Genetics Corporation

Treatment of pouchitis.

Atlantic Healthcare Limited

Treatment of peripheral T-cell lymphoma




all-cis-docosa-4,7,10,13,16,19-hexaenoic acid


Treatment of skin blistering and erosions associated with inherited epidermolysis bullosa

allogeneic cardiosphere-derived cells




n/a 12/2/2010 Fate Therapeutics, Inc.

n/a 2/18/2013

n/a 8/22/2011

allogeneic cord blood cells, ex vivo modulated with 16,16 dimethyl prostaglandin E2 (dmPGE2)

Enhancement of stem cell engraftment through ex vivo treatment of human allogeneic hematopoietic stem cells (treatment of neuropenia, thrombocytopenia, lymphopenia, and anemia).

allogeneic ex-vivo expanded placental adherent stromal cells

Treatment of Aplastic Anemia

Pluristem Therapeutics, Inc.

allogeneic ex-vivo expanded placental adherent stromal cells

Treatment of thromboangiitis obliterans (Buerger's disease)

Pluristem Therapeutics, Inc.



Atir 2/2/2010

n/a 7/24/2012 Neurotech USA, Inc.

allopregnanolone n/a 4/20/2014 Sage Therapeutics

allopregnanolone n/a 7/12/2013

n/a 3/24/2015

allogeneic hematopoietic stem cell

Prevention (reduction) of transplant related mortality (TRM, which is caused by graft versus host disease and/or infections) following mismatched (haploidentical) allogeneic hematopoietic stem cell transplantation.

Kiadis Pharma Netherlands B.V.

allogenic retinal epithelial cells transfected with plasmid vector expressing ciliary neurotrophic growth factor

Treatment of macular telangiectasia type 2 (MacTel)

Treatment of status epilepticus

Treatment of Neimann-Pick disease, type C


allosteric activator of the red blood cell-specific form of pyruvate kinase

Treatment of pyruvate kinase deficiency

Agios Pharmaceuticals, Inc.



n/a 9/2/2010

Glassia 7/28/2011 Kamada, Ltd.

Glassia 10/23/2014 Kamada Ltd.

n/a 10/21/2010

n/a 1/29/2010 Grifols Therapeutics, Inc.

Prolastin(R)-C 3/3/2015 Grifols Therapeutics, Inc.

n/a 4/6/2012 Grifols Therapeutics, Inc.

n/a 2/20/2009 CSL Behring LLC

alpha melanotropin

Treatment of chronic beryllium disease

mondoBIOTECH Laboratories AG

alpha-1 proteinase inhibitor (human)

Treatment of patients with recent onset (

alpha-1 proteinase inhibitor (human)

Treatment of graft versus host disease

alpha-tocotrienol quinone

Treatment of inherited mitochondrial respiratory chain diseases.

Edison pharmaceuticals, Inc.

alpha1 proteinase inhibitor (human)

Treatment of emphysema secondary to congenital alpha1-antitrypsin deficiency.

alpha1-proteinase inhibitor (human)

Treatment of Type 1 diabetes mellitus patients with residual beta-cell function.







alteplase Activase 1/27/2003 Daniel F. Hanley, MD

altiratinib n/a 8/19/2014

alvocidib n/a 4/21/2014

amatuximab n/a 9/28/2012 Morphotek, Inc.

ambrisentan Letairis 7/16/2004 Gilead Colorado

ambroxol n/a 6/29/2011 Belrose Pharma, Inc.

n/a 3/3/2015 Catalyst Pharmaceuticals

n/a 11/12/2009

amikacin sulfate n/a 1/5/2015 PlumeStars s.r.l.

Treatment of intraventricular hemorrhage associated with intracerebral hemorrhage




Tolero Pharmaceuticals, Inc.




amifampridine phosphate

Treatment of congenital myasthenic syndromes

amifampridine phosphate

Treatment of Lambert-Eaton Myasthenic Syndrome

Catalyst Pharmaceuticals, Inc.

Management of cystic fibrosis patients with Pseudomonas aeruginosa lung infections



Levulan 3/20/2007

aminosidine Paromomycin 3/29/2005

Amiket(Tm) 1/19/2010

n/a 5/5/2008

amphotericin B n/a 9/15/2010 iCo Therapeutics Inc.

amrubicin n/a 3/10/2008 Celgene Corporation

amylopectin n/a 3/24/2015

n/a 12/22/2011 uniQure, B.V.

anakinra Kineret 8/19/2010

aminolevulinic acid hydrochloride

Treatment of esophageal dysplasia

DUSA Pharmaceuticals, Inc.

Treatment of visceral leishmaniasis

The Institute for One World Health

amitriptyline and ketamine

Treatment of postherpetic neuralgia

Immune Pharmaceuicals, Inc.

ammonium tetrathiomolybdate


Pipex Pharmaceuticals, Inc.

Treatment of visceral leishmaniasis.


Treatment of glycogen storage disease types Ia and Ib

Michael K. Davis, MD, MBA

an adeno-associated viral vector containing a codon-optimised human factor IX gene (AAV5-hFIXco)


Treatment of cryopyrin-associated periodic syndromes

Swedish Orphan Biovitrum AB (publ)



andexanet alfa n/a 2/23/2015 Portola Pharmaceuticals

angiotensin (1-7) n/a 8/30/2013 US Biotest, Inc.

For reversing the anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgery

Treatment of patients requiring stem cell transplantation to accelerate the mobilization of hematopoietic stem cells (CD34+) from the bone marrow to the peripheral blood when combined with a granulocyte colony-stimulating factor




angiotensin 1-7 n/a 1/29/2010 W. Jeffrey Petty, MD

angiotensin 1-7 n/a 6/17/2010 US Biotest, Inc.

anisina n/a 7/14/2015 Novogen Ltd

n/a 11/17/2014 ChemoCentryx, Inc.

angiotensin (1-7)[A(1-7)]


Treatment of sarcoma.

To accelerate engraftment of hematopoietic cells (treatment of neutropenia, thrombocytopenia, lymphoma, and aneima)in hematopoietic stem cell transplants.

Treatment of neuroblastoma.

antagonist of the complement 5a receptor

Treatment of atypical hemolytic uremic syndrome



n/a 6/2/2014 ChemoCentryx, Inc.

n/a 12/23/2014

n/a 9/3/2009

n/a 7/29/2008

n/a 10/20/2008

n/a 1/13/2015 OncoSynergy, Inc.

antagonist of the complement 5a receptor

Treatment of anti-neutrophil cytoplasmic autoantibodies associated vasculitides (granulomatosis with polyangiitis or Wegener's granulomatosis), microscopic polyangiitis, and Churg-Strauss syndrome.

antagonist of the endosomal Toll-like receptors (TLRs) 7, 8, and 9


Idera Pharmaceuticals, Inc.

anthrax immune globulin

Treatment of inhalation anthrax disease

Emergent Biosolutions, Inc.

anthrax immune globulin (human)

Treatment of inhalational anthrax

Cangene Corp. - Emergent Biosolutions

anti human Nogo-A human monoclonal antibody

Treatment of acute spinal cord injury


anti-Beta1 integrin monoclonal antibody




n/a 9/13/2013 Xenikos BV

n/a 12/2/2008 Xencor, Inc.

n/a 3/9/2012 Recepta Biopharma S.A.

3/26/2010 Neovii Biotech NA, Inc.

n/a 9/12/2008 Neovii Biotech NA, Inc.


anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein and anti-CD7 mAb (WT1)-ricin A chain fusion protein


anti-CD30 Fc engineered humanized monoclonal antibody


anti-Lewis Y humanized monoclonal antibody

Treament of ovarian cancer

anti-T-lymphocyte immune globulin, rabbit

Atg-Fresenius(R)

Prevention of graft versus host disease (GVHD)

anti-T-lymphocyte immune globulin, rabbit

Prophylaxis of acute allograft rejection in adult recipients in solid organ transplantation

anti-TCR murine monoclonal antibody (MAB, type IgM)

Treatment of pediatric multiple sclerosis in patients less than or equal to 16 years of age




Feiba 4/12/2013 Baxalta US, Inc.

n/a 11/18/2003

n/a 9/23/2013 ProQR Therapeutics B.V.

anti-TCR murine monoclonal antibody (MAb, type IgM)

Treatment of patients 16 years of age and younger with immune-mediated T1DM and preserved pancreatic beta cell function

anti-inhibitor coagulant complex

Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in hemophilia A and B patients with inhibitors

anti-interferon-gamma Fab from goats

For the treatment of immunologic corneal allograft rejection

Advanced Biotherapy, Inc.

anti-sense oligonucleotide consisting of 2Ã¿Æ¿Ã¿â¿¿Ã¿â¿¿Ã¿Â¢Ã¿Æ¿Ã¿Â¢Ã¿Â¢Ã¢â¿¿Â¬Ã¿Â¡Ã¿â¿¿Ã¿Â¬Ã¿Æ¿Ã¿Â¢Ã¿Â¢Ã¢â¿¿Â¬Ã¿Â¾Ã¿â¿¿Ã¿Â¢0-Me RNA with a phosphorothioate backbone




Thymoglobulin 5/25/2010 Genzyme Corporation

n/a 11/17/2014

10/16/2002 AEterna Zentaris, Inc.

n/a 7/21/2014

Eloctate 11/23/2010 Biogen Idec Inc.

anti-thymocyte globulin [rabbit]

Prophylaxis of acute organ rejection in patients receiving renal transplants

anti-tumor necrosis factor (TNF) polyclonal antibody (bovine)

Treatment of pediatric ulcerative colitis (0 through 16 years of age)

Avaxia Biologics, Incorporated

antiangiogenic components extracted from marine cartilage

Neovastat (Ae-941)


antibody drug conjugate consisting of fully human anti-guanylyl cyclase C monoclonal antibody linked to the cytotoxic drug monomethyl auristatin E



antihemophilic factor (recombinant), Fc fusion protein

Treatment of hemophilia A



Obizur 3/16/2004

n/a 7/5/2012

n/a 11/21/2008

n/a 2/3/2015

Gti-2040 3/12/2003 Lorus Therapeutics, Inc

antihemophilic factor (recombinant), porcine sequence

Treatment and prevention of episodic bleeding in patients with inhibitor antibodies to human coagulation factor VIII


antimesothelin-ADC (antibody drug conjugate)


Bayer HealthCare Pharmaceuticals, Inc.

antineoplaston A10, antineoplaston AS2-1


Burzynski Research Institute, Inc.

antinuclear antibody conjugated liposomal doxorubicin

Treatment of Ewing's sarcoma.

NanoSmart Pharmaceuticals, Inc.

antisense 20-mer phosphorothioate oligonucleotide [complementary to the coding region of R2 component of the human ribonucleotide reductase mRNA]

Treatment for renal cell carcinoma




antroquinonol n/a 7/23/2015

antroquinonol Hocena(R) 4/30/2015

antroquinonol n/a 1/21/2015

n/a 12/3/2012

apremilast n/a 1/17/2013 Celgene Corporation

arimoclomol n/a 3/29/2005 CytRx Corporation

n/a 1/13/2015 Orphazyme ApS

aripiprazole Abilify 1/25/2006

antisense oligonucleotide targeted to human transthyretin (TTR) mRNA

Treatment of familial amyloid polyneuropathy


Golden Biotechnology Corporation


Golden Biotechnology Corporation


Golden Biotechnology Corp.

apolipoprotein E mimetic peptide


LipimetiX Development, LLC



arimoclomol citrate

Treatment of Neimann-Pick disease, type C

Treatment of Tourette's syndrome

Otsuka Pharmaceutical Development



arsenic Trisenox 11/2/2001

arsenic trioxide Trisenox 6/13/2003



n/a 11/2/2015 Orsenix Holdings BV

Coartem 8/31/2007 Novartis Pharmaceuticals

n/a 2/27/2008

Treatment of acute myelocytic leukemia subtypes M0, M1, M2, M4, M5, M6 and M7


Treatment of liver cancer





Teva Branded Pharmaceutical Products R*D, Inc.

arsenic trioxide capsule (oral)


artemether/lumefantrine

For the treatment of infections due to Plasmodium falciparum or mixed infections including P. falciparum.

arylsulfatase A (rhASA)

Treatment of metachromatic leukodystrophy




astuprotimut-R n/a 5/29/2009

ataluren n/a 3/10/2008 PTC Therapeutics, Inc.

ataluren Translarna 12/10/2014 PTC Therapeutics, Inc.




Treatment of MAGE-A3 positive non-small cell lung cancer

GlaxoSmithKline Biologicals, S.A.


Treatment of mucopolysaccharidosis type I

For use in the treatment of cystic fibrosis resulting fron a nonsense (premature stopcodon) mutation in the cystic bibrosis transmembrane conductance regulatory gene

Treatment of Muscular Dystrophy resulting from premature stop mutations in the dystrohin gene

Treatment of aniridia



auranofin Ridaura 4/30/2010

n/a 1/15/2015

n/a 4/19/2012 bluebird bio, Inc.

n/a 3/18/2013 bluebird bio, Inc.

Treatment of amebiasis

Ctr for Discovery & Innovation in Parasitic Diseas

autologous CD34+ bone marrow derived stem cells transduced with a self-inactivating gammaretroviral vector encoding the human IL2RG (yc)

Treatment of severe combined immune deficiency-X1

Boston Children's Hospital

autologous CD34+ hematopoietic stem cells tranduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA

Treatment of andrenoleukodystrophy

autologous CD34+ hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human BA-T87Q-globin gene

Treatment of B-thalassemia major and intermedia



n/a 2/26/2014 bluebird bio Inc.

n/a 11/6/2014 Juno Therapeutics, Inc.

n/a 11/19/2013 iREG Medical AB

n/a 3/9/2015 Cell Medica, Inc.

autologous CD34+ hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human BA-T87Q-globin gene

For the treatment of Sickle Cell Disease

autologous CD4+/CD8+ T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19

Treatment of acute lymphoblastic leukemia (inclusive of B-cell acute lymphoblastic leukemia)

autologous CD4+CD25hiFoxP3+regulatory T cells

Prevention of graft rejection following solid organ transplantation

autologous Epstein-Barr virus specific T-cells

Treatment of Epstein-Barr virus positive non-Hodgkin lymphomas.



n/a 3/14/2014

n/a 10/22/2014 Mayo Clinic

n/a 10/21/2014

n/a 5/6/2014 Amphera BV

Alecsat 9/13/2013 CytoVac A/S

autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19



autologous adipose derived mesenchymal stromal cells


autologous bone marrow CD34+ cells transduced ex vivo with a self activating HIV-1 -based lentiviral vector, EFS-ADA

Treatment of adenosine deaminase deficient severe combined immunodeficiency

Donald B. Kohn, MD - Professor, UC-UCLA

autologous dendritic cells pulsed with allogeneic tumor cell lysate


autologous ex vivo expanded CD4+-enriched leukocytes treated with the de-methylating agent 5-aza-2Ã¢â¿¬â¿¢-deoxycytidine




n/a 6/10/2014

4/3/2008

n/a 6/7/2011 Tengion, Inc.

Rhinocytes 12/31/2008 RhinoCyte, Inc.

n/a 3/27/2014 Kite Pharma, Inc.

autologous genetically modified human dermal fibroblasts

Treatment of dystrophic epidermolysis bullosa.

Fibrocell Technologies, Inc.

autologous lymphocytes depleted ex vivo of immunoreactive T cells using 4,5


Treatment of chronic graft versus host disease


autologous neo-uninary conduit

Treatment of bladder dysfunction requiring incontinent urinary diversion.

autologous olfactory neural progenitors


autologous peripheral blood T lymphocytes transduced with retroviral vector containing anti CD19 CD28/CD3 zeta chimeric antigen receptor




n/a 5/6/2015

Oncophage 5/10/2002 Agenus, Inc.

Oncophage 7/11/2002 Agenus, Inc.

n/a 7/24/2012 Duke University

n/a 8/26/2009 Glaxo Group Limited

avicin d n/a 3/24/2015 Avicin Therapeutics Ltd.

autologous tumor cells fused with polyethylene glycol to human allogeneic FO-1, DNA plasmid transfected tumor cell line


Sebastiano Gattoni-Celli, MD

autologous tumor-derived gp96 heat shock protein-peptide complex


autologous tumor-derived gp96 heat shock protein-peptide complex


autologous umbilical cord blood

Treatment of pediatric (0-16 yrs old inclusive) cerebral palsy due to acquired brain injury

autologus CD34+ cells transfected with retroviral vector containing adenosine deaminase gene

Treatment of severe combined immunodeficiency due to adenosine deaminase deficiency.




aviptadil n/a 2/22/2005

azacitidine Vidaza 12/3/2001 Celgene Corporation

aztreonam Cayston 3/12/2002

baclofen n/a 12/16/1991 AngioDynamics, Inc.

baclofen Gablofen 10/28/2015 Mallinckrodt, Inc.


Mondobiotech Laboratories AG

Treatament of myelodysplastic syndromes

Inhalation therapy for control of gram-negative bacteria in the respiratory tract of patients with cystic fibrosis

Gilead Sciences (formerly Corus Pharma)

Treatment of intractable spasticity due to multiple sclerosis or spinal cord injury.

Treatment of complex regional pain syndrome.



baclofen 11/10/1987 Medtronic, Inc.

baclofen n/a 12/2/2003 Medtronic Neurological

n/a 9/26/2013 4D Pharma Research Ltd

bardoxolone n/a 3/30/2015

basimglurant n/a 3/9/2012 Hoffmann-La Roche, Inc.

beclomethasone n/a 3/4/2009 Aptalis Pharma US, Inc.

Lioresal Intrathecal

Treatment of intractable spasticity caused by spinal cord injury, multiple sclerosis, and other spinal diseases (including spinal ischemia, spinal tumor, transverse myelitis, cervical spondylosis, and degenerative myelopathy).

Treatment of dystonia

bacterium Bacteroides thetaiotaomicron

Treatment of active Crohn's disease in the pediatric population


Reata Pharmaceuticals, Inc.

Treatment of Fragile X Syndrome

Treatment of pediatriac patients with ulcerative colitis



Orbec(R) 7/24/2009 Soligenix, Inc.

Bec 8/28/2001 Soligenix, Inc.

n/a 11/19/2012 Soligenix, Inc


beclomethasone 17,21-dipropionate

Treatment of gastrointestinal symptoms with chronic graft versed host disease in patients undergoing allogenic hematopoietic cell transplantation


Prevention of gastrointestinal graft-versus-host disease


Prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster

beclomethasone 17,21-diproprionate

Treatment of pediatric patients with Crohn disease.



Sirturo 1/10/2005

belatacept Nulojix 2/20/2008

beloranib n/a 1/15/2013 Zafgen, Inc.

n/a 7/2/2014

bedaquiline; (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol

Treatment of active tuberculosis

Janssen Research & Development, LLC

Prophylaxis of organ rejection in renal allograft recipients


Treatment of Prader-Willi syndrome

bendamustine for 50 ml admixture


Eagle Pharmaceuticals, INc.



n/a 7/2/2014bendamustine for 50ml admixture

Treatment of Follicular Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Splenic Marginal Zone Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-Associated Lymphoma Tissue (MALT), and Nodal Marginal Zone Lymphoma (Collectively Indolent B-cell Non-Hodgkin's Lymphoma)

Eagle Pharmaceuticals, Inc.



Treanda 11/26/2013 Cephalon, Inc.

n/a 9/10/2013 Supratek Pharma, Inc.

benznidazole n/a 4/14/2014 Chemo Research, S.L.

benzoate Naben 7/6/2012

bendamustine hydrochloride

Treatment of Follicular Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Splenic Marginal Zone Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-Associated Lymphoma Tissue (MALT), and Nodal Marginal Zone Lymphoma (Collectively Indolent B-cell Non-Hodgkin's Lymphoma)

bendamustine hydrochloride with betadex sulfobutyl ether sodium


Treatment of Chagas disease

Treatment of pediatric schizophrenia

SyneuRx International (Taiwan) Corp.



Ammonul 11/22/1993

n/a 12/22/2011 Lung Rx, Inc.

betamethasone n/a 10/7/2015 Grace Therapeutics, LLC

bevacizumab Avastin 11/23/2010 Genentech, Inc.

bevacizumab n/a 10/21/2010


benzoate/phenylacetate

Treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.

Medicis Pharmaceutical Corp.

beraprost sodium 314d


Treatment of Ataxia Telangiectasia.

Treatment of fallopian tube carcinoma

Treatment of hereditary hemorrhagic telangiectasia

Terence M. Davidson, MD

In combination with a platinum and 5-FU or capecitabine for the treatment of stomach cancer.









bezafibrate Bezalip 7/24/2013

Fang 10/22/2014 Gradalis, Inc.

Therapeutic treatment of patients with ovarian cancer


Treatment of primary peritoneal carcinoma.



Treatment of melanoma stages IIb through IV as part of a combination chemotherapy regimen

For therapeutic treatment of Barth syndrome

Barth Sydrome Foundation, Inc.

bi-shRNA furin and GMCSF Autologous Tumor Cell Vaccine






n/a 3/24/2008

n/a 1/16/2003

binimetinib n/a 7/31/2014 Array Biopharma, Inc.

binimetinib n/a 11/19/2013 Array BioPharma, Inc.

bi-shRNAfurin and granulocyte macrophage colony stimulating factor augmented autologus tumor cell vaccine


bi-shRNAfurin and granulocyte macrophage colony stimulating factor augmented autologus tumor cell vaccine

Treatment of stage IIB to IV melanoma

bifidobacterium infantis 35624

Treatment of pediatric ulcerative colitis

Alimentary Health Limited

bifidobacterium longum infantis 35624

Treatment of pediatric Crohn's disease

Alimentary Health Limited


Treatment Stage IIB-IV melanoma.



Normocarb Hf 8/9/2005 Dialysis Solutions, Inc.

bisantrene HCl n/a 2/14/2014 Update Pharma, Inc.

n/a 8/8/2013

n/a 8/8/2013

n/a 9/14/2011 Sanofi-Aventis US, Inc.

n/a 2/10/2015 Bristol-Myers Squibb Co.

biocarbonate infusate

Use in the management of patients undergoing continuous renal replacement therapy with hemofiltration


bispecific antibody (monoclonal antibody)

Treatment of HER2-expressing advanced adenocarcinoma of the stomach and gastroesophageal junction

Merrimack Pharmaceuticals, inc.

bispecific antibody (monoclonmal antibody)

Treatment of HER2-expressing adenocarcinoma of the esophagus

Merrimack Pharmaceuticals, Inc.

bispecific antibody targeting interleukin 4 (IL-4) and interleukin 13 (IL-13)


bivalent anti-human myostatin adnectin-IgG1

Treatment of duchenne muscular dystrophy



bivalirudin Angiomax 11/2/2005 The Medicines Company

blinatumomab n/a 2/6/2006 Amgen, Inc.




bortezomib Velcade 5/30/2012


For use as an anticoagulant in patients with or at risk of heparin-induced thrombocytopenia/heparin-induced thrombocytopenia thrombosis syndrome

Treatment of indolent B-cell lymphoma, excluding CLL and NHL with CNS involvement

Treatment of prolymphocytic leukemia

Treatment for hairy cell leukemia.

Treatment of acute lymphocytic leukemia



Treatment of follicular non-Hodgkin lymphoma






bosutinib Bosulf 2/24/2009

n/a 6/29/2011 Cangene Corporation

bovine lactoferrin n/a 2/19/2015

bovine lactoferrin n/a 2/23/2015

Adcetris 10/23/2008 Seattle Genetics, Inc.







botulism antitoxin heptavalent (A, B, C, D, E, F, G) (Equine)

Treatment of botulism.

Prevention of late-onset sepsis in very low birth weight infants

Metrodora Therapeutics, Inc.

Prevention of necrotizing enterocolitis in very low birth weight infants (birth weight less than or equal to 1500 grams)

Metrodora Therapeutics, Inc.

brentuximab vedotin

Treatment of anaplastic large cell lymphoma






Adcetris(R) 1/31/2014 Seattle Genetics, Inc.


brilliant blue G Brilliant Peel 12/16/2009

bryostatin 1 n/a 3/31/2015

brentuximab vedotin

Treatment of patients with peripheral T-cell lymphoma, not otherwise specified

brentuximab vedotin

Treatment of Hodgkin's lymphoma

brentuximab vedotin

Treatment of patients with angioimmunoblastic T-cell lymphoma

brentuximab vedotin

Treatment of patients with diffuse large B-cell lymphoma.

brentuximab vedotin

Treatment of mycosis fungoides

For use in ophthalmic surgery to aid in the removal of the inner limiting membrane of the eye.

Fluron GmbH - Subsidiary of Geuder AG

Treatment of Fragile X Syndrome.

Neurotrope BioScience, Inc.



bryostatin-1 n/a 12/3/2001 GPC Biotech, Inc.

budesonide Uceris 5/6/2013 Santarus, Inc.

budesonide Nefecon 5/17/2010 Pharmalink AB

bupivacaine Transdur 6/18/2008 Impax Laboratories, Inc.

Suboxone 10/27/1994

For use in combination with paclitaxel in the treatment of esophageal cancer

Treat of ulcerative colitis in pediatric patients aged 0 through 16 years.

To slow the progression of immunoglobulin A nephropathy & delay kidney failure in patients affected by the disease.

Relief of persistent pain associated with postherpetic neuralgia

buprenorphine in combination with naloxone

Treatment of opiate addiction in opiate users

Reckitt Benckiser Pharmaceuticals, Inc.



busulfan Partaject 11/25/2002 SuperGen, Inc.

n/a 8/5/2015 Everfront Biotech, Inc.

cabozantinib Cometriq 11/29/2010 Exelixis, Inc.

n/a 8/22/2012

n/a 12/20/2010

Preparative therapy for pediatric patients undergoing bone marrow transplantation

butylidenephthalide

Treatment of Malignant Glioma

Treatment of follicular, medullary and anaplastic thyroid carcinoma and metastatic or locally advanced papillary thyroid cancer.

caffeine and sodium benzoate

Treatment of seizure prolongation in patients undergoing electroconvulsive therapy


calcium benzoate and risperidone

Treatment of pediatric patients with schizophrenia

University of California, Los Angeles



calfactant Infasurf 6/7/1985 ONY, Inc.

calfactant Infasurf 9/5/2000 ONY, Inc.

camostat n/a 5/18/2011 NIXS Corporation

canakinumab Ilaris 12/5/2013


canakinumab n/a 9/4/2012

Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants.

Treatment of acute respiratory distress syndrome (ARDS)

Treatment of chronic pancreatitis

Treatment of hyperimmunoglobulinemia D and periodic fever syndrome


Treatment of pediatric (age 16 and under) juvenile rheumatoid arthritis.


Treatment of TNF-receptor associated periodic syndrome (TRAPS)






cannabidiol n/a 4/22/2015 GW Pharma Ltd.

cannabidiol n/a 7/1/2014 Insys Therapeutics, Inc.




cannabidiol n/a 7/14/2015 Talent biotechs Ltd.



Treatment of cryopyrin-associated periodic syndromes


Treatment of familial mediterranean fever


Treatment of neonatal hypoxic ischemic encephalopathy

Treatment of Dravet syndrome

Treatment of Lennox-Gastaut syndrome

Treatment of glioma

Treatment of infantile spasms

Prevention of Graft versus Host Disease (GVHD).


Treatment of pediatric schizophrenia (pediatrics is defined as 0 through 16 years of age)



cannabidiol n/a 11/14/2013 GW Pharma Ltd.

cannabidiol; n/a 2/27/2014 GW Pharma Ltd.

cantharidin n/a 7/24/2012 Orenova Group, LLC

cantrixil n/a 4/20/2015 CanTx, Inc.

n/a 10/28/2009

n/a 2/14/2014

capsaicin n/a 10/23/2002 Acorda Therapeutics, Inc.

capsaicin Qutenza 5/2/2003 Acorda Therapeutics, Inc.

Treatment of Dravet syndrome.

Treatment of Lennox-Gastaut syndrome

Treatment of perforating diseases, including Kyrle's disease, reactive perforating collangenosis, perforating folliculitis and elastosis perforans serpiginosa


caprine hyperimmune serum against HIV lysate


Daval International Limited

caprine hyperimmune serum against HIV lysate


Daval International Limited

Treatment of erythromelalgia




capsaicin Qutenza 5/22/2009 Acorda Therapeutics, Inc.

carbenoxolone n/a 7/2/2014

carbetocin n/a 4/11/2014

carbon monoxide n/a 9/28/2012

n/a 2/10/2015

cardiotrophin-1 n/a 10/16/2014 Digna Biotech, S.L.

cardiotrophin-1 n/a 6/24/2008 Digna Biotech, S.L.

cardiotrophin-1 n/a 9/13/2011 Digna Biotech S.L.

Management of neuropathic pain in patients with postherpetic neuralgia

Treatment of Huntington's Disease

Oxalys Pharmaceuticals, Inc.

Treatment of Prader Willi syndrome

Ferring Pharmaceuticals, Inc.


Hillhurst Biopharmaceuticals, Inc.

carboxy pyrrolidine hexanoyl pyrrolidine carboxylate

Treatment of AL amyloidosis

Glaxo Group Limited, England d/b/a GlaxoSmithKline

Prevention of ischemia-reperfusion injury in kidney transplant recipients

To protect the liver from ischemia-reperfusion injury inherent to the procedure of transplantation.




carfilzomib Kyprolis 1/18/2008 Onyx Therapeutics, Inc.

carglumic acid Carbaglu 1/20/1998 Orphan Europe SARL

carglumic acid Carbaglu 6/17/2014 Orphan Europe SARL

carisbamate n/a 3/16/2012 SK Life Science, Inc.

carlumab n/a 10/24/2006 Centocor, Inc.

catumaxomab n/a 7/1/2009

cediranib n/a 12/13/2010

celiprolol n/a 1/5/2015 Acer Therapeutics, Inc.

Apocell 3/18/2013 Enlivex Therapeutics Ltd.

cenersen Aezea 6/18/2008 Eleos, Inc.

cenersen Aezea 2/27/2008 Eleos, Inc.


Treatment of N-acetylglutamate synthetase deficiency.

Treatment of organic acidemias

Management of patients with infantile spasms



Neoviibiotech North America, Inc.



Treatment of Ehlers-Danlos syndrome

cell based therapeutic composed of allogeneic donor apoptotic cells

Prevention of graft versus host disease

Treatment of stage IIB through IV melanoma




cenersen n/a 5/8/2006 Eleos, Inc.

ceritinib Zykadia 9/27/2013

cethromycin Restanza(Tm) 9/9/2009

cethromycin Restanza(Tm) 9/9/2009

cethromycin n/a 2/28/2007

cetuximab Erbitux 7/3/2000


Treatment of patients with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase(ALK)-positive


Prophylactic treatment of tularemia due to Francisella tularensis.

Advanced Life Sciences, Inc.

Prophylactic treatment of plague due to Yersinia pestis

Advanced Life Sciences, Inc.

Prophylactic treatment of patients exposed to inhalation anthrax.

Advanced LIfe Sciences, Inc.

Treatment of squamous cell cancer of the head and neck in patients who express epidermal growth factor receptor

ImClone Systems Incorporated



Oncorad Ov103 4/24/1990 Cytogen Corporation

n/a 2/12/2007

chenodiol Chenadal 3/22/2010 Retrophin, Inc.

chenodiol Chenix 9/21/1984 Solvay

n/a 11/25/2014

chelmab-y or chelamusab-Y


chenodeoxycholic acid




For patients with radiolucent stones in well opacifying gallbladders, in whom elective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age

chimeric fusion protein of recombinant human alpha-N-acetylglucosaminidase and human insulin-like growth factor 2

Treatment of mucopolysaccharidosis III Type B (MPS IIIB, Sanfilippo Syndrome Type B)




n/a 3/18/2013

n/a 9/26/2013

n/a 11/20/2012

Patul-End 2/18/1997 Ear Foundation

chloropyramine n/a 10/22/2010

chloroquine n/a 5/20/2015 DualTpharma B.,V.

chlorotoxin n/a 12/2/2008 Morphotek, Inc.

n/a 6/23/2015 Blaze Bioscience, Inc.


chimeric monoclonal antibody against Claudin 6


Ganymed Pharmaceuticals AG

chimeric monoclonal antibody against claudin-18 splice variant 2


Ganymed Pharmaceuticals AG

chimeric monoclonal antibody to claudin 18 splice variant 2


GANYMED Pharmaceuticals AG

chlorobutanol/propylene glycol/hydrochloric acid

Treatment of patulous eustachian tube


CurFAKtor Pharmaceuticals, LLC


Treatment of stage IIb, IIc, III & IV melanoma

chlorotoxin conjugated to indocyanine green dye

Diagnostic for the management of malignant brain tumors

cholest-4-en-3-one, oxime

Treatment of spinal muscular atrophy.



cholic acid Cholbam 7/18/2003 Retrophin, Inc.

n/a 8/25/2011 Wilson Therapeutics AB

n/a 12/22/2014 JDS Therapeutics, LLC

cinacalcet Sensipar 4/30/2010 Amgen, Inc.

cinacalcet Sensipar 5/12/2003 Amgen, Inc.

Treatment of inborn errors of cholesterol and bile acid synthesis and metabolism

choline tetrathiomolybdate


chromium picolinate and chromium histidinate

Treatment of pediatic polycystic ovary syndrome (0 through 16 years of age)

Treatment of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo surgery

Treatment of hypercalcemia in patients with parathyroid carcinoma



ciprofloxacin n/a 6/1/2011 Aradigm Corporation

ciprofloxacin DPI 2/2/2010

n/a 4/17/2014

n/a 1/19/2010

civamide n/a 2/17/2009

civamide Zucapsaicin 12/9/2002

The management of bronchiectasis

Ciprofloxacin Pulmosphere(R)

Management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients


ciprofloxacin dry powder inhaler

Treatment of non-cystic fibrosis bronchiectasis


cis-adamantane-2-spiro-3'-8'-[4'-[2'-(4'-morpholinyl)ethoxy]phenyl]-1',2,'4'-trioxaspiro[4.5] decane mesylate

Treatment of malaria caused by Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, or Plasmodium malariae

Medicines for Malaria Venture (MMV)

Treatment of postherpetic neuralgia.

Winston Laboratories, Inc.

Treatment of postherpetic neuralgia of the trigeminal nerve

Winston Laboratories, Inc.



cladribine n/a 3/19/2015

n/a 4/26/2011 RedHill Biopharma Ltd.

clenbuterol 10/27/2014

clobazam Onfi 12/18/2007 Lundbeck, Inc.

clofarabine Clofarex 3/14/2002

clofarabine Clolar 2/7/2002 Genzyme Corporation

clofazimine Lamprene 6/25/2014

Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorder

Chord Therapeutics S.a.r.l.

clarithromycin, rifabutin, clofazimine

Treatment of pediatric Crohn's disease.

Spiropent, Ventipulmin

Adjunctive therapy with enzyme replacement therapy in the treatment of Pompe disease

Duke University Medical Center

Treatment of Lennox-Gastaut Syndrome


Genzyme Corp (Ilex Products, Inc.)


Treatment of active tuberculosis




Rixubis 10/31/2012 Baxalta US, Inc.

Novoseven Rt 6/18/2004 Novo Nordisk Inc.

Tretten 11/6/2003 Novo Nordisk, Inc.

cobimetinib n/a 1/31/2014 Genentech, Inc.

n/a 12/19/2007

coagulation factor IX (recombinant)

Prophylactic use to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (routine prophylaxis in patients where there is no evidence or suspicion of bleeding)

coagulation factor VIIa (recombinant)

Treatment of bleeding episodes in Glanzmann's thrombasthenia

coagulation factor XIII A-subunit (recombinant)

Prophylaxis of bleeding associated with congential factor XIII deficiency

Treatment of stage IIb, IIc, III, and IV melanoma with BRAFV600 mutation

coccidioidin SD Skin Test Antigen

For the diagnosis of Coccidioidomycosis

Allermed Labortories, Inc.



n/a 3/14/2011 NBI Pharmaceuticals, Inc.

colchicine Colcrys 9/25/2007

Xiaflex 5/23/1996

Xiaflex 3/12/1996

n/a 11/19/2012 OXiGENE, Inc.

Transmid 12/3/2001 Xenova Biomedix Limited

Cobartin 7/18/2003 Jarrow Formulas, Inc.

copanlisib n/a 2/5/2015

copper histidine n/a 5/14/2012 Stephen G. Kaler, M.D.

coenzyme Q10 and d-alpha-tocopherol

Treatment of Friedreich's Ataxia.

Treatment of familial Mediterranean fever

AR Holding Company, Inc.

collagenase clostridium histolyticum

Treatment of advanced (involutional or residual stage) Dupuytren's disease.

Auxilium Pharmaceuticals, Inc.

collagenase clostridium histolyticum

Treatment of Peyronie's disease.

Auxilium Pharmaceuticals, Inc.

combretastatin A 1 diphosphate


conjugate of human transferrin and a mutant diphtheria toxin (CRM 107)

Treatment of malignant tumors of the central nervous system

conjugated bile acids

Treatment of steatorrhea in patients with short bowel syndrome



Treatment of Menkes disease



corifungin n/a 7/6/2011

corifungin n/a 8/22/2011

creatine Creapure 2/12/2002 Avicena Group, Inc.

crenolanib n/a 10/31/2012

crenolanib n/a 3/18/2011

n/a 12/20/2010

cridanimod n/a 1/12/2011 Kevelt Ltd.

crizotinib Xalkori 9/28/2012 Pfizer, Inc.


Sandler Center for Drug Discovery

Treatment of amebic meningoencephalitis.

Ctr for Discovery & Innovation in Parasitic Diseas



AROG Pharmaceuticals, LLC



crenolanib besylate



Treatment of progesterone receptor negative endometrial cancer in conjunction with progesterone therapy.

Treatment of anaplastic large cell lymphoma



crizotinib Xalkori 9/13/2010 Pfizer, Inc.

crizotinib Xalkori 10/31/2012 Pfizer

n/a 8/15/2003

n/a 11/5/2009

n/a 6/24/2013

Treatment of ALK-positive, MET-positive, or ROS-positive non-small cell lung cancer


cultured, partially T-Cell depleted, allogenic thymic tissue for transplantation

As a therapy for primary immune deficiency resulting from athymia associated with complete DiGeorge Syndrome

Duke University Medical Center

cyclic pyranopterin monophosphate (cPMP)

Treatment of molybdenum cofactor deficiency type A (MoCD)


cyclo(-y-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonly-L-phenylalanyl-N-3-carboxypropyl)-glycine amide, acetate salt

Treatment of acromegaly

Aspireo Pharmaceuticals Limited



cyclocreatine n/a 6/18/2012 Lumos Pharma

Cyrevia(Tm) 6/7/2011

Cyrevia(Tm) 6/17/2011

cyclosporine n/a 2/17/2009 Sigmoid Pharma Limited

cyclosporine n/a 2/17/2009 Sigmoid Pharma Limited

n/a 8/1/1991 Allergan, Inc.

cyclosporine A n/a 9/30/2008 Santen SAS

Treatment of creatine transporter deficiency

cyclophosphamide


Accentia Biopharmaceuticals, Inc.

cyclophosphamide

Prevention of graft versus host disease following allogeneic hematopoietic stem cell transplant

Accentia Biopharmaceuticals, Inc.

Treatment of graft-versus-host disease

Prophylaxis of graft-versus-host disease

cyclosporine 2% ophthalmic ointment

For use in corneal melting syndromes of known or presumed immunologic etiopathogenesis, including Mooren's ulcer

Prevention of corneal graft rejection



cyclosporine A Nova22007 4/9/2008 Santen SAS

11/23/2010

cysteamine n/a 8/6/2008

cysteamine n/a 9/11/2013

cysteamine n/a 5/9/2008 Raptor Therapeutics

Procysbi 10/24/2006 Raptor Therapeutics, Inc.

Depocyt 1/30/2007 Bruce Frankel, MD


Treatment of herpes simplex virus stromal keratitis

cyclosporine; ciclosporin

Neurostat(R)/Ciclomulsion(R)

Treatment of moderate to severe traumatic brain injury.

NeuroVive Pharmaceutical AB

Treatment of neuronal ceroid lipofuscinoses (Batten disease)

Raptor Pharmaceuticals, Inc.


Raptor Pharmaceuticals, Inc.


cysteamine enteric coated

Treatment of cystinosis

cytarabine liposome


cytochrome C, flavin mononucleotide and thiamin diphosphate

Treatment of mitochondrial disorders



n/a 12/17/2014 Nuvilex, Inc.

n/a 11/5/2014

dabrafenib Tafinlar 1/12/2011

dabrafenib Tafinler 10/20/2014

n/a 10/29/2015

dacetuzumab n/a 8/13/2004 Seattle Genetics, Inc.

cytochrome P450 isoform 2B1 gene transfected human embryonic kidney 293 cells encapsulated in polymeric cellulose sulphate

Treatment of pancreatic cancer in combination with ifosfamide

d6-tetrabenazine, deutetrabenazine


Teva Pharmaceuticals, Inc.

Treatment BRAF V600 mutation positive Stage IIB through IV melanoma


Treatment of patients with BRAF mutation positive non-small cell lung cancer


dabrafenib and trametinib

Treatment of patients with BRAF mutation positive non-small cell lung cancer.





dacetuzumab n/a 10/6/2005 Seattle Genetics, Inc.

dacomitinib n/a 3/3/2015 Pfizer, Inc.

dalbavancin Dalvance 3/30/2015

dalfampridine Ampyra 6/2/1987 Acorda Therapeutics

n/a 9/25/2012

Ryanodex 8/16/2013

daratumumab 11/9/2015

daratumumab n/a 8/6/2015

daratumumab n/a 8/20/2015

daratumumab 5/6/2013


Treatment of non-small cell lung cancer with EGFR, HER2, HER4, or DDR2 mutations.

Treatment of acute osteomyelitis in children (0 through 16 years of age)

Durata Therapeutics International B.V.

Relief of symptoms of multiple sclerosis

dantrolene sodium

Treatment of heat stroke


dantrolene sodium suspension for injection

Treatment of malignant hyperthermia syndrome


Humax (R) - Cd38


Janssen Research and Development, LLC





Humax(R)-Cd38





dasiprotimut-T Biovax Id 6/17/2010 Biovest International, Inc.

dasiprotimut-T Biovaxid 10/28/2009 Biovest International, Inc.

davunetide n/a 12/7/2009 Allon Therapeutics, Inc.

debrase Debridase 8/20/2003 MediWound, Ltd.

decitabine Dacogen 3/8/1999

defactinib n/a 2/12/2015 Verastem, Inc.

deferasirox Exjade 2/24/2015

deferiprone n/a 9/1/2011 ApoPharma, Inc.

deferiprone Ferriprox 12/12/2001



Treatment of progressive supranuclear palsy.

Debridement of acute, deep dermal burns in hospitalized patients


Otsuka Pharmaceutical Development


Treatment of chronic iron overload in alpha-thalassemia


Treatment of superficial siderosis

Treatment of iron overload in patients with hematologic disorders requiring chronic transfusion therapy

ApoPharma, Inc. A Division of



deferiprone n/a 7/31/2008 ApoPharma, Inc.

n/a 12/21/1998 Biomedical Frontiers, Inc.

n/a 1/28/2005 Biomedical Frontiers, Inc.

defibrotide n/a 1/8/2007 Gentium SpA

defibrotide n/a 5/21/2003 Gentium SpA

deflazacort Calcort 9/16/2010

deflazacort n/a 8/16/2013

Treatment of Friedreich's ataxia

deferoxamine starch conjugate

Treatment of chronic iron overload resulting from conventional transfusional treatment of beta-thalassemia major and sickle cell anemia.

deferoxamine starch conjugate

Treatment of acute iron poisoning

For the prevention of hepatic veno-occlusive disease.

For the treatment of hepatic veno-occlusive disease


University of Rochester Medical Center





deflazacort n/a 10/22/2015

n/a 3/16/2012

Ablysinol 9/11/2013

n/a 12/2/2011 ReveraGen Biopharma

demcizumab n/a 4/30/2014

Treatment of pediatric (0 through 16 years of age) juvenile idiopathis arthritis (JIA) International League of Associations for Rheumatology (ILAR) categories excluding systemic JIA.


dehydrated alcohol



dehydrated alcohol

Treatment of hypertrophic obstructive cardiomyopathy

Belcher Pharmaceuticals, LLC

delta-1,4,9(11)-pregnatriene-17-alpha,21-dihydroxy-16-alpha-methyl-3,20-dione



OncoMed Pharmaceuticals, Inc.



n/a 6/7/2010

Neuroblaxin 9/23/2011

n/a 7/12/2013 Eisai Inc.

Ontak 4/30/2010 Eisai, Inc.

n/a 6/29/2011 Eisai, Inc.

Ontak 8/21/1996 Eisai, Inc.

denosumab Xgeva 9/11/2013 Amgen, Inc.

denosumab Xgeva 12/20/2010 Amgen, Inc.

dendritic cells pulsed with synthetic peptides derived from antigens MAGE1, HER-2, AIM-2,TRP-2, gp100 and interleukin-13 receptor alpha

Treatment of glioblastoma or brain stem glioma

ImmunoCellular Therapeutics Ltd.

dendritic hybrid cell vaccine


Orbis Health Solutions, LLC

denileukin diftitox


denileukin diftitox


denileukin diftitox

Treatment of peripheral T-cell lymphoma (PTCL)

denileukin diftitox

Treatment of patients with cutaneous T-cell lymphoma

Treatment of hypercalcemia in malignancy

Treatment of patients with giant cell tumor of bone



deutetrabenazine n/a 1/13/2015 Auspex Pharmaceuticals

Ozurdex 9/11/1998 Allergan

n/a 12/2/2008

n/a 7/24/2012 EryDel S.p.A.

Treatment of Tourette syndrome in the pediatric population (defined as 0 through 16 years of age)

dexamethasone intravitreal implant

Treatment of non-infectious ocular inflammation of the posterior segment in patients with intermediate, posterior, and panuveitis

dexamethasone phosphate

Treatment of corneal graft rejection.

EyeGate Pharmaceuticals, Inc.

dexamethasone sodium phosphate encapsulated in autologous erythrocytes

Treatment of ataxia-telangiectasia



dexanabinol n/a 8/11/2004 Pharmos Corporation

dexpramipexole n/a 10/11/2007 Knopp Biosciences LLC

dexrazoxane Totect(R) 3/25/2004 Biocodex

n/a 8/19/2014 Satiscor, LLC

dextran 1 n/a 3/21/2003 BCY LifeSciences Inc.

diacerein n/a 10/15/2014 TWI Biotechnology, Inc.

For the attenuation or amelioration of the long-term neurological sequelae associated with moderate and severe traumatic brain injury


Treatment of anthracycline extravasation during chemotherapy

dexrazoxane hydrochloride

Prevention of cardiomyopathy for chilren and adolescents 0 through 16 years of age treated with anthracyclines





diannexin n/a 10/28/2009

n/a 7/31/2012 Acorda Therapeutics, Inc.

n/a 11/16/2015

n/a 5/30/2013

diazoxide n/a 12/3/2012 Sedogen, LLC

diazoxide choline n/a 5/13/2014 Essentialis, Inc.

n/a 9/2/2010 Taro Pharmaceuticals

Prevention of ischemia-reperfusion injury in solid organ transplants


diazepam (intranasal)

Management of patients with acute repetitive seizures

diazepam (intranasal)

Management of acute repetitive seizures.

Neurelis Pharmaceuticals, Inc.

diazepam auto-injector

Management of selected, refractory patients with epilepsy on stable regimens of antiepileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity

Meridian Medical Technologies-a Pfizer subsidiary

Treatment of Prader Willi Syndrome

Treatment of Prader-Willi Syndrome

dichlorphenamide

Treatment of primary periodic paralyses



n/a 4/14/2004 CIS-US

n/a 6/13/2003

difluprednate Durezol 9/30/2008

digitoxin n/a 5/27/2005 Silver Pharmaceuticals

digitoxin n/a 11/2/2001 SimRx Advisors LLC

digitoxin n/a 10/18/2001 SimRx Advisors LLC

n/a 2/3/2012 Velo Bio, LLC

diethylenetriaminepentaacetate (DPTA)

For treatment of patients with known or suspected internal contamination with plutonium, americium or curium to increase the rates of elimination.

diferuloylmethane


Allertein Therapeutics, LLC

Treatment of endogenous and traumatic anterior uveitis and panuveitis.

Alcon Pharmaceuticals. Ltd.




digoxin immune fab (ovine)

Treatment of severe preeclampsia and eclampsia



Eurartesim 1/8/2007

dimebon n/a 5/12/2009 Medivation, Inc.

n/a 9/11/2013 Gino Cortopassi

n/a 5/9/2008

dinaciclib n/a 8/25/2011

dinutuximab n/a 12/20/2010

dihydroartemisinin and piperaquine

Treatment of uncomplicated malaria caused by "Plasmodium falciparum," Plasmodium vivax," Plasmodium malariae," or "Plasmodium ovale."


Treatment of Huntington's Disease.

dimethyl fumarate

Treatment of Friedreich's Ataxia

dimethyl sulfoxide

For use in combination with antimicrobial drugs for the treatment of drug resistant tuberculosis

Abela Pharmaceuticals, Inc.


Merck Sharp & Dohme Ltd.


United Therapeutics Corporation



n/a 6/13/2003 Lloyd E. King, Jr.

n/a 6/1/2015

n/a 4/27/2015 Sancilio & Company, Inc.

n/a 12/17/2014

domperidone n/a 9/2/2011

diphenylcyclopenone

Treatment of chronic severe forms of alopecia areata (Alopecia Totalis [AT]/Alopecia Universalis [AU])

docosahexaenoic acid

Treatment of short bowel syndrome

Sancilio and Company, Inc.

docosahexaenoic acid


docosahexaenoic acid, DHA


Sancilio and Company, Inc.

Treatment of hypoprolactinemia in breastfeeding mothers, and in some hypoprolactinemic conditions following the use of cabergoline or bromocriptine in mothers who wish to initiate or return to breastfeeding

Thomas W. Hale, RPh, PhD



n/a 1/26/2015 Silenseed Ltd

n/a 6/9/2015

dovitinib n/a 9/26/2013

doxofylline n/a 2/14/2014

doxorubicin n/a 8/25/2009 Delcath Systems, Inc.

doxorubicin n/a 4/6/2015 Louis D. Falo, Jr.

Doxil 12/29/2004

3/14/2005 BioAlliance Pharma

n/a 2/20/2008 Supratek Pharma, Inc.

double stranded RNA which targets the mutated KRAS oncogene


double stranded oligomer AD00370 RNA interference-based liver targeted therapeutic

Treatment of Alpha-1 Antitrypsin deficiency

Arrowhead Research Corporation

Treatment of adenoid cystic carcinoma


Treatment of bronchiectasis

Alitair Pharmaceuticals, Inc.



doxorubicin HCL liposome injection


Johnson & Johnson Pharmaceutical Research & Dev.

doxorubicin PIHCA nanoparticles

Doxorubicin Transdrug


doxorubicin with pluronics F-127 and L-61




droxidopa Northera 1/17/2007 Lundbeck LLC

n/a 8/7/2014 Birken AG

duvelisib n/a 4/15/2013 Infinity Pharmaceuticals

n/a 6/18/2007 Amicus Therapeutics, Inc

ecallantide Kalbitor 2/4/2003 Dyax Corp.

echinomycin n/a 5/21/2015 OncoImmune, Inc.

n/a 6/2/2014 Makindus, Inc.

Treatment of neurogenic symptomatic orthostatic hypotension in patients with primary autonomic failure, dopamine-beta-hydroxylase deficiency, and nondiabetic autonomic neuropathy.

dry extract from Betulae Cortex (birch bark)


Treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma

duvoglustat hydrochloride

Treatment of Pompe disease



echothiophate iodide

Treatment of Stargardt's disease



n/a 7/21/2009

n/a 9/29/2010

eculizumab Soliris 10/18/2011

eculizumab n/a 3/5/2001




ecopipam hydrochloride

Symptomatic treatment of self injurious behaviors in patients with Lesch-Nyhan disease.

Psyadon Pharmaceuticals, Inc.

ecopipam hydrochloride

Treatment of Tourette's syndrome in children 0-16 years old.

Psyadon Pharmaceuticals, Inc.

Treatment of Shiga-Toxin producing escherichia coli hemolytic uremic syndrome


Treatment of idiopathic membranous glomerular nephropathy


Prevention of delayed graft function after renal transplantation


Treatment of neuromyelitis optica


Treatment of paroxysmal nocturnal hemoglobinuria




eculizumab n/a 6/12/2014


edaravone n/a 3/12/2015 Treeway B.V.

efaproxiral n/a 7/28/2004 Allos Therapeutics, Inc.

eflornithine n/a 2/4/2011

eflornithine n/a 11/23/2010

eflornithine HCL n/a 4/7/2015

n/a 1/22/2013

n/a 3/8/2011 S.L.A. Pharma Ltd. (UK)

Treatment of Myasthenia Gravis.


Treatment of atypical hemolytic uremic syndrome



Adjunct to whole brain radiation therapy for the treatment of brain metastases in patients with breast cancer

Treatment of Familial Adenomatous Polyposis

Cancer Prevention Pharmaceuticals


Cancer Prevention Pharmaceutical, Inc.


Cancer Prevention Pharmaceuticals, Inc.

eflornithine plus sulindac

Treatment of familial adenomatous polyposis

Cancer Prevention Pharmaceuticals, Inc.

eicosapentaenoic acid




elacytarabine n/a 6/18/2008 Clavis Pharma ASA

eliglustat Cerdelga 9/17/2008 Genzyme Corporation

elosulfase alfa Vimizim 5/15/2009

elotuzumab n/a 9/1/2011

eltrombopag Promacta 11/8/2013

eltrombopag Promacta 5/5/2008

emricasan n/a 11/20/2013


Treatment of Type I Gaucher disease

Use in the treatment of mucopolysaccharidosis (MPS) Type IV A (Morquio A syndrome)

BioMarin Pharmaceutical Inc.



Treatment of aplastic anemia


Treatment of idiopathic thrombocytopenia purpura


Treatment of liver transplant recipients with reestablished fibrosis to delay the progression to cirrhosis and end stage liver disease

Conatus Pharmaceuticals Inc.



Epaned 1/30/2013

n/a 8/19/2015 Seres Health, Inc.

n/a 1/10/2014

encorafenib n/a 11/19/2013 Array BioPharmas, Inc.

n/a 11/19/2013 Array BioPharma, Inc.

eniluracil n/a 12/15/2005

ensituximab n/a 10/21/2010 Neogenix Oncology, Inc.

enalapril maleate (powder for oral solution)

Treatment of hypertension in pediatric patients

Silvergate Pharmaceuticals, Inc.

encapsulated spores from fecal microbiota

Treatment of recurrent Clostridium difficile infection (CDI)

enchochleate amphotericin B


Aquarius Biotechnologies, Inc.

Treatment of Stage IIB-IV melanoma positive for BRAF mutation

encorafenib + binimetinib

Treatment in Stage IIB-IV melanoma positive for the BRAF mutation.


Adherex Technologies, Inc.





enzastaurin n/a 3/4/2009 Denovo Biopharma LLC

epoprostenol Flolan 3/22/1999 GlaxoSmithKline

epratuzumab Lymphocide 7/13/1998 Immunomedics, Inc.

epratuzumab n/a 9/30/2008 Immunomedics, Inc.

n/a 4/20/2012 Thrombologic

erdosteine n/a 12/20/2013

entrectinib;N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide



Treatment of secondary pulmonary hypertension due to intrinsic precapillary pulmonary vascular disease.

Treatment of non-Hodgkin's lymphoma


eptifibatide and iloprost

Treatment of purpura fulminans

Treatment of bronchiectasis.

Alitair Pharmaceuticals, Inc.



eribulin mesylate Halaven(R) 5/14/2012 Eisai, Inc.

estradiol Gel n/a 10/31/2006

etanercept Enbrel 10/27/1998 Immunex Corporation

etarfolatide n/a 2/16/2000 Endocyte, Inc.

eteplirsen n/a 10/23/2007

Treatment of advanced soft tissue sarcoma

Estrogen replacement therapy in females with Turner syndrome

Ascend Therapeutics US, LLC

Reduction in signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.

For the identification of ovarian carcinomas





ethanolamine Ethamolin 1/17/2014 QOL Medical, LLC

Lipiodol 9/26/2013 Guerbet LLC

n/a 4/18/2011 Nektar Therapeutics

everolimus Afinitor 6/8/2009

Prophylactic use in pediatric patients (age 0 through 16 years) with esophageal varices that are at risk of bleeding to obliterate varices and to prevent bleeding

ethiodized oil injection

Management of patients with known hepatocellular carcinoma (HCC)

etirinotecan pegol


Treatment of tuberous sclerosis complex including TSC-associated subependymal giant cell astrocytoma (SEGA), TSC-associated angiomyolipoma and TSC-associated lymphangioleiomyomatosis (LAM)





everolimus n/a 6/2/2014


n/a 9/10/2015

evolocumab Repatha 9/12/2013 Amgen Inc.

n/a 5/8/2014 iCell Science AB

Prochymal(R) 4/30/2010 Mesoblast, Inc.

n/a 12/20/2010 TCA Cellular Therapy, LLC







everolimus ointment

Topical treatment of Tuberous Sclerosis Complex-related skin lesions

Aucta Pharmaceuticals, LLC


ex vivo cultured human mesenchymal stromal cells

Prevention of graft rejection following solid organ transplantation

ex-vivo cultered adult human mesenchymal stem cells

Treatment of Type 1 diabetes patients with residual beta cell function

ex-vivo expanded autologous bone marrow-derived mesenchymal stem cells




exendin-(9-39) n/a 6/1/2011

n/a 1/23/2013

n/a 8/20/2009 Intercytex Ltd.

n/a 8/22/2013 ReNeuron Ltd

n/a 11/19/2012 Invenux, LLC

Treatment of congential hyperinsulinenic hypoglycemia and other causes of hyperinsulinemic hypoglycemia in adults and children

The Children's Hospital of Philadelphia

exon 53 specific phosphorothioate oligonucleotide

treatment of Duchenne Muscular Dystrophy patients bearing mutations that can be corrected by skipping exon 53


expanded allogeneic human dermal fibroblasts in hypothermosol(r)-FRS

Treatment of Dystrophic Epidermolysis Bullosa.

expanded human allogeneic neural retinal progenitor cells extracted from neural retina


extract of sorghum bicolor extract




Telintra 1/9/2013 Telik, Inc.

n/a 1/10/2014 Genentech

Corifact 1/16/1985 CSL Behring LLC

farletuzumab n/a 6/16/2006 Morphotek, Inc.

fecal microbiota n/a 3/10/2014 Rebiotx, Inc.

fenfluramine HCI Brabafen 12/20/2013 Zogenix, Inc.

fenretinide n/a 9/4/2013 CerRx, Inc.

fenretinide n/a 9/4/2013 CerRx, Inc.

fenretinide n/a 2/1/2007 Cancer Research UK

ezatiostat hydrochloride


factor VIII mimetic bispecific antibody


factor XIII concentrate (human)

Treatment of congenital factor XIII deficiency


Treatment of recurrent Clostridium difficile infection (Clostridium difficile gastrointestinal disease)

For the Treatment of Dravet Syndrome



Treatment of Ewing's sarcoma family of tumors.



n/a 6/26/2003 Degussa AG

ferumoxytol n/a 10/7/2011

ferumoxytol n/a 4/6/2012 ArsNova Partners, LLC

ferumoxytol Feraheme 4/29/2011 Edward A. Neuwelt, MD

ferric hexacyanoferrate (II) "Prussian Blue"

Treatment of patients with known or suspected internal contamination with radioactive or non-radioactive cesium or thallium

For use in magnetic resonance imaging in brain metastases

Oregon Health & Science University

For use in magnetic resonance imaging to assess, and monitor treatment of solid tumor malignancies previously diagnosed in pediatric patients (age 16 years and younger)

For use in MR imaging for the mangement of brain tumors



fialuridine n/a 7/24/1992

fidaxomicin Dificid 12/13/2010

filanesib n/a 5/6/2014 Array BioPharma, Inc.

filgrastim n/a 1/27/2015

filgrastim Neupogen 11/20/2013 Amgen, Inc.

filociclovir n/a 11/29/2010 Microbiotix, Inc.

fingolimod n/a 4/30/2010

Adjunctive treatment of chronic active hepatitis B.

Oclassen Pharmaceuticals, Inc.

Treatment of pediatric Clostridium difficile infection

Optimer Pharmaceuticals, Inc.


Treatment of amyotrophic lateral sclerosis (ALS)

Neurovision Pharma GmbH

Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident

Treatment of active cytomegalovirus infections

Treatment of chronic inflammatory demyelinating polyneuropathy




firtecan pegol n/a 4/18/2011

flubendazole n/a 1/23/2014

flubendazole n/a 10/25/2013

n/a 4/7/2015

n/a 6/24/2013

n/a 1/19/2011 Forest Laboratories, Inc.

n/a 11/28/2008


Enzon Pharmaceuticals, Inc.

Treatment of lymphatic filariasis caused by nematodes of the family Filariodidea, in children and adults.

Janssen Research and Development, LLC

Treatment of onchocerciasis caused by Onchocerca volvulus


fluciclovine (18F)(anti-1-amino-3-fluorocyclobutane-1-carboxylic acid, labelled with Fluorine-18)

For the diagnosis of glioma

Blue Earth Diagnostics Ltd.

flunarizine hydrochloride

Treatment of alternating hemiplegia


fluticasone propionate

Treatment of pediatric and adult eosinophilic esophagitis

fosfomycin/tobramycin

Treatment of pulmonary infections associated with cystic fibrosis

CURx Pharmaceuticals, Inc.



n/a 8/25/2015

fresolimumab n/a 10/21/2010

n/a 6/9/2015 XOMA (US) LLC

n/a 10/16/2013 Versartis, Inc.

gabapentin Gralise 11/8/2010 Depomed, Inc.

gabapentin Neurontin 7/5/1995

Horizant 6/7/2011 XenoPort, Inc.

ganaxolone n/a 3/24/2015

fostamatinib disodium

Treatment of immune thrombocytopenic purpura

Rigel Pharmaceuticals, INc.

Treatment of primary focal segmental glomerulosclerosis

Genzyme, a Sanofi Company

fully human IgG2 monoclonal antibody that binds insulin receptors

Treatment of congenital hyperinsulinism

fusion protein analog with recombinant human growth hormone (rhGH) at once-a-month dosing

Treatment of growth hormone deficiency




gabapentin enacarbil


Treatment of Protocadherin 19 (PCDH19) female epilepsy.

Marinus Pharmaceuticals, Inc.



ganciclovir Zirgan 3/22/2007 Sirion Therapeutics, Inc.

ganitumab n/a 11/23/2010 Amgen

gefitinib Iressa 8/26/2014

gemcabene n/a 2/6/2014

n/a 6/24/2015

n/a 6/24/2015

n/a 2/4/2009 Memgen, LLC

n/a 4/29/2002 Aettis, Inc.

gevokizumab n/a 2/21/2014 XOMA (US) LLC

Treatment of acute herpetic keratitis (dendritic and geographic ulcers)


Treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer



Gemphire Therapeutics, Inc.

gemcitabine ready-to-use


Sun Pharmaceutical Industries Ltd.

gemcitabine ready-to-use


Sun Pharmaceutical Industries Ltd.

gene encoding chimeric CD40 ligand


genetically engineered herpes simplex virus (G207)


Treatment of pyoderma gangrenosum





givinostat n/a 4/12/2013 Italfarmaco SpA

Copaxone 11/14/2007 Teva Neurosciences, Inc.

n/a 1/12/2011

glucagon n/a 12/5/2012 Biodel, Inc.


Treatment of non-infectious intermediate, posterior or pan uveitis, or chronic non-infectious anterior uveitis

Treatment of Duchenne Muscular Dystrophy and Becker Muscular Dystrophy

glatiramer acetate

Treatment of amyotrophic lateral sclerosis (ALS).

glioma derived cell lysates and irradiated cells


Epitopoietic Research Corp.

Prevention of hypoglycemia in the congenital hyperinsulinism population



glucagon infusion G-Pump (Tm) 9/25/2014

glucarpidase Voraxaze 8/19/2003 BTG International Inc.

glufosfamide n/a 9/18/2006

glyburide n/a 9/29/2015

glycafilin n/a 8/22/2008

Ravicti 4/27/2009

Prevention of chronic, severe hypoglycemia related to congential hyperinsulinism

Xeris Pharmaceuticals, Inc.

Treatment of patients at risk of methotrexate toxicity

For treatment of pancreatic cancer.



Remedy Pharmaceuticals, Inc.

Prevention of delayed graft function after solid organ transplantation

ProtAffin Biotechnologie AG

glycerol phenylbutyrate

Maintenance treatment of patients with deficiencies in enzymes of the urea cycle

Hyperion Therapeutics, Inc.



glycopyrrolate Cuvposa 6/9/2006 Shionogi, Inc.

glycopyrrolate 2% n/a 6/17/2010

n/a 9/27/2012 Cytheris, Inc.

n/a 10/23/2013

n/a 2/11/2015

golimumab Simponi Aria 4/2/2015

golimumab Simponi 3/16/2012 Janssen Biotech, Inc.

10/28/2009 GenVec, Inc.

Treatment of pathologic (chronic moderate to severe) drooling in pediatric patients

Treatment of Frey's syndrome

Wellesley Therapeutics, Inc.

glycosylated recombinant human interleukin-7

Treatment of progressive multifocal leukoencephalopathy

glycyl-L-2-methylprolyl-L-glutamic Acid


Neuren Pharmaceuticals, Ltd.

glycyl-L-2-methylpropyl-L-glutamic acid


Neuren Pharmaceuticals, Ltd.

Treatment of polyarticular juvenile idiopathic arthritis in pediatric patients (o through 16 years of age)



golnerminogene pradenovec

Tnferade(Tm) Biologic




n/a 8/27/2008 DrugRecure Aps


guadecitabine n/a 9/29/2015

guanfacine Tenex 8/5/1999 Watson Laboratories, Inc.

n/a 6/29/2011 Nordic Group B.V.

n/a 9/3/2009

n/a 10/13/2011 Halo Theraeputics, LLC

granulocyte macrophage colony stimuling factor


granulocyte-macrophage colony stimulating factor-coding oncolytic adenovirus, Ad5/3-D24-GMCSF



Astex Pharmaceuticals, Inc.

Treatment of fragile X syndrome.

gusperimus trihydrochloride

Treatment of Wegener's granulomatosis

gylceryl tri (4-pheynlybutyrate)

For intermittent or chronic treatment of patients with cirrhosis and any grade hepatic encephalopathy.

Hyperion Therapeutics, Inc.

halofuginone hydrobromide




Cadi Mw 9/3/2004

Cadi Mw 11/21/2002 CPL, Inc.

Cadi-Mw 7/31/2012

n/a 9/23/2014

n/a 8/27/2014

n/a 5/29/2014

heat killed Mycobacterium w immunomodulator

Active tuberculosis

Cadila Pharmaceuticals Limited, Inc.

heat killed mycobacterium w immunomodulator

Adjuvant to multi-drug therapy in the management of multibacillary leprosy

heat killed mycobacterium w immunomodulator

Treatment of non-small cell lung cancers that express desmocollin-3

Cadila Pharmaceuticals Limited

heat killed whole cell mycobacterium obuense


Immodulon Therapeutics Limited

hematopoietic stem and progenitor cells expanded ex-vivo with a low molecular weight aryl hydrocarbon receptor (AHR) antagonist

Hematopoietic support in patients with acute lymphoblastic leukemia (ALL)


heparan sulfate mimetic


Momenta Pharmaceuticals, Inc.



n/a 10/24/2011

Hepagam 3/24/2008 Cangene Corporation

Hepabig Gene 5/6/2013 Green Cross Corp.

n/a 12/17/2014 Immunitor, Inc.

n/a 12/23/2014 Karcinolys S.A.S.

heparin activated recombinant human fibroblast growth factor 1 (FGF1)in combination with a surgically implanted biodegradable device

Treatment of patients with a confirmed traumatic complete spinal cord injury where no motor or sensory function is preserved below the injury(Scale A)

BioArctic Neuroscience AB

hepatitis B immune globulin (human)

Prevention of hepatitis B recurrence following orthotopic liver transplant

hepatitis B virus neutralizing human monoclonal antibody

Prevention of hepatitis B recurrence following liver transplantation

hepcortespenlisimut-L


herpes simplex type 1 virus containing cellular B-myb gene as tumor-specific promoter




n/a 1/13/2012 Promethera Biosciences

n/a 3/9/2012 Promethera Biosciences

n/a 12/2/2012 Laboratoris Sanifit, S.L.

n/a 2/8/2002 American BioScience, Inc.

n/a 5/11/2011 Alfact Innovation SAS

n/a 10/16/2013 MedImmune

n/a 7/6/2012 Galileo Research srl

n/a 11/9/2015 Bone Therapeutics SA

Allob 1/10/2014 Bone Therapeutics SA

heterologous human adult liver derived progenitor cells (HHALPC)

Treatment of urea cycle disorders

heterologous human liver derived progenitor cells

Treatment of Crigler-Najjar syndrome

hexasodium phytate

Treatment of calciphylaxis

homoharringtonine

Treatment for chronic myelogenous leukemia

human Hepatocarcinoma-Intestine-pancreas/pancreatitis associated protein


human IgG1k monoclonal antibody


human MHC non-restricted cytotoxic T-cell line


human allogeneic bone marrow derived osteoblastic cells

Treatment of osteogenesis imperfecta.

human allogeneic bone marrow derived osteoblastic cells

Treatment of osteonecrosis



Humax-Cd4 8/13/2004

n/a 7/29/2008

Octanate 12/3/2012 OCTAPHARMA USA, Inc.

Hemoleven 11/8/2007

n/a 11/3/2015 Shire

Riastap 3/13/2008 CSL Behring, LLC

n/a 6/19/2014

human anti-CD4 monoclonal antibody


Emergent Product Development Seattle, LLC

human anti-cellular adhesion molecule-1 monoclonal antibody


BioInvent International AB

human coagulation factor VIII

Immune tolerance induction in hemophilia A patients with inhibitors

human coagulation factor XI

Treatment of severe congential Factor XI deficiency.

Laboratoire francais du Fractionnement et des Biot

human cystic fibrosis transmembrane conductance regulator (hCFTR) messenger RNA (mRNA) complexed with branched polyethyleneimine (bPEI)

Treatment of patients with cystic fibrosis.

human fibrinogen concentrate, pasteurized

Treatment of fibrinogen deficient patients.

human fully IgG1 antibody specific for CD33





Oralgam 9/16/2002 Latona Life Sciences, Inc.



Q-Cells 9/11/2013 Q Therapeutics, Inc.

n/a 11/19/2013

n/a 2/14/2011 Cytonet GmbH & Co. KG

n/a 4/6/2015 Nutrinia, Ltd.

human gammaglobulin

Treatment of gastrointestinal disturbances (to include constipation, diarrhea, and abdominal pain) associated with regression-onset autism in pediatric patients.

human gammaglobulin

Treatment for juvenile rheumatoid arthritis

human gammaglobulin

Treatment of idiopathic inflammatory myopathies

human glial restricted progenitor cells and their progeny


human haptoglobin


BioProducts Laboratory Limited

human heterologous liver cells


human insulin (rDNA)

Treatment of short bowel syndrome (SBS).



n/a 2/11/2013 Orban Biotech, LLC

n/a 2/18/2011

n/a 6/6/2013

n/a 9/23/2011 Prothelia, Inc.

n/a 1/26/2015

n/a 7/7/2005 IRX Therapeutics, Inc.

human insulin beta chain peptide with incomplete Freund's adjuvant vaccine

Treatment of Type 1 diabetes patients with residual beta cell function

human interleukin-3 genetically conjugated to diphtheria toxin protein


Stemline Therapeutics, Inc.

human interleukin-3 genetically conjugated to diphtheria toxin protein

Treatment of blastic plasmacytoid dendritic cell neoplasm


human laminin-111

Treatment of merosin (laminin-alpha2) deficient congential muscular dystrophy type 1A.

human leukocyte antigen-A2 restricted peptides



human leukocyte-derived cytokine mixture

Neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck



n/a 10/21/2010

n/a 10/15/2013

n/a 11/26/2013 Dyax Corporation

n/a 1/6/2010 Kenta Biotech Limited

n/a 6/7/2010 Kedrion, S.p.A.

Tromplate 6/27/2013 Prophylix Pharma AS

human monoclonal anti-PA antibody

For post-exposure prophylaxis and treatment of inhalation anthrax.

Emergent Product Development Gaithersburg, Inc.

human monoclonal antibody againt human interleukin 13 (IL-13)

Treatment of eosinophilic esophagitis

Novartis Pharmaceuticals Corporaton

human monoclonal antibody directed against active plasma kallikrein

Treatment of hereditary angioedema (HAE)

human monoclonal antibody directed against serotype O1 Pseudomonas aeruginosa

Treatment of pneumonia caused by serotype O1 positive Pseudomonas aeruginosa

human plasminogen

Treatment of ligneous conjunctivitis

human platelet antigen-1a immunoglobulin (anti-HPA-1a)

Prevention of fetal and neonatal alloimmune thrombocytopenia



n/a 7/6/2012 FibroGen, Inc.

n/a 12/22/2014

n/a 7/23/2012 jCyte, Inc.

n/a 10/14/2015 Atara Biotherapeutics

n/a 2/4/2011 Neuralstem, Inc.

human recombinant DNA-derived, IgG1 kappa monoclonal anti-body to connective growth factor


human recombinant mesencephalic, astrocyte derived neurotrophic factor



human retinal progenitor cells


human soluble receptor-Fc fusion protein that targets human activin A


human spinal cord derived neural stem cells




n/a 10/22/2014

n/a 10/1/2009

Pneumostem 11/26/2013 MEDIPOST America, Inc.

n/a 12/1/2014 MorphoSys AG

human trtravalent, bi-specific monoclonal antibody that binds and co-inhibits two growth factor receptors; insulin-like growth factor receptor 1 (IGF-1R) and v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3 (ErbB3)



human tumor necrosis factor coupled to the C terminus of CNGRCG peptide

Treatment of liver cancer

Molecular Medicine S.p.A. (Molmed)

human umbilical cord blood-derived mesenchymal stem cells


humanized Fc engineered monoclonal antibody against CD19




n/a 4/29/2014 MorphoSys AG

n/a 2/17/2012

n/a 5/26/2011 MENTRIK Biotech, LLC

n/a 7/22/2008

n/a 12/12/2011 Opsona Theraeputics

n/a 6/30/2014 Chugai Pharma USA, LLC

humanized Fc engineered monoclonal antibody against CD19

Treatment of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma

humanized IgG1 anti-serum amyloid A monoclonal antibody

Treatment of AA amyloidosis and AL amyloidosis

Prothena Therapeutics Limited

humanized IgG1 monoclonal anti-CD20 antibody


humanized IgG2 antibody

Treatment of vaso-occlusive crisis in patients with sickle cell disease.

Selexys Pharmaceuticals Corp.

humanized IgG4 monoclonal antibody

Prevention of ischemia/reperfusion injury associated with solid organ tranplantation

humanized anti-IL-6R receptor neutralizing IgG2 monoclonal antibody

Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorder



n/a 5/22/2014 Sanofi U.S. Services, Inc.

n/a 9/11/2014 Synthetic Biologics, Inc.

n/a 8/5/2010 Biogen Idec, Inc.

n/a 8/20/2015 Stanford University

n/a 5/5/2015


humanized immunoglobulin monoclonal antibody against CD38


humanized monoclonal antibodies hu1B7 and hu11E6

Treatment of Bordetella pertussis

humanized monoclonal antibody against human integrin alphaVbeta6


humanized monoclonal antibody of the IgG4 kappa isotype targeting CD47

Treatment of acute myeloid (myelogenous) leukemia.

humanized monoclonal antibody that targets the a-subunit of the human IL-3 receptor also known as the CD123 antigen; (JNJ-56022473)



humanized monoclonal antibody to tissue factor




n/a 6/18/2008 Stromedix, Inc.

n/a 11/17/2011

n/a 12/3/2009 MedImmune

hyaluronic acid n/a 3/19/2002 CoTherix

Transkrip(R) 3/17/2011 Neolpharma S.A.DE C.V.

Transkrip(R) 3/17/2011 Neolpharma S.A.DE C.V.

n/a 3/9/2015 Alsonex Pty Ltd

humanized monocloncal antibody against human integrin alphaVbeta6

Treatment of fibrosis-associated chronic allograft nephropathy in kidney transplant patients.

humanized single chain monoclonal antibody(scFV: IgG1 hinge: IgG1 CH2 and CH3 domains)


Emergent Product Development Seattle, LLC

humanized, afucosylated IgG1 kappa monoclonal antibody

Treatment of scleroderma

Treatment of emphysema in patients due to alpha-1 antitrypsin deficiency

hydralazine - magnesium valproate


hydralazine - magnesium valproate


hydrocinnamate-[Orn-Pro-dCha-Trp-Arg](CH3COO)




Chronocort(R) 9/3/2015 Diurnal Ltd.

Chronocort 3/18/2015 Diurnal Limited

Duocort 6/18/2008 Shire ViroPharma, Inc.

Infacort(R) 5/13/2015 Diurnal Limited

Siklos 7/24/2013 addmedica Laboratories

Makena 1/25/2007

hydroxyurea Pedroxa 3/16/2015

hydroxyurea n/a 4/15/2005

hydrocortisone modified release capsules

Treatment of adrenal insufficiency.

hydrocortisone modified release capsules

Treatment of congenital adrenal hyperpasia

hydrocortisone modified release tabs

Treatment of adrenal insufficiency

hydrocortisone oral granules

Treatment of pediatric adrenal insufficiency (0 through 16 years of age).

hydroxycarbamide (hydroxyurea)

Treatment of sickle cell disease in patients under 18 years of age

hydroxyprogesterone caproate

Prevention of preterm birth in singleton pregnancies

KV Pharmaceutical Company

Treatment of symptomatic sickle cell disease in pediatric patients, less than 17 years of age.

Ebelle D'Ebelle Pharmaceuticals LLC

Treatment of pediatric patients with sickle cell anemia.

UPM Pharmaceuticals, Inc.



ibalizumab n/a 10/20/2014 TaiMed Biologics, Inc.

Zevalin 9/6/1994

ibrutinib Imbruvica 10/15/2013 Pharmacyclics, LLC



ibrutinib n/a 9/8/2014 Pharmacyclics, LLC


Treatment of HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy

ibritumomab tiuxetan

Treatment of B-cell non-Hodgkin's lymphoma.




Treatment of splenic marginal zone lymphoma









ibudilast n/a 6/1/2015 MediciNova, Inc.

icatibant Firazyr 11/25/2003 Shire Orphan Therapies

idarucizumab n/a 5/28/2015

Treatment of nodal marginal zone lymphoma


Treatment of small lymphocytic lymphoma

Treatment of chronic lymphocytic leukemia (CLL)

Treatment of Krabbe disease.


To reverse the anticoagulant effect of dabigatran due to uncontrolled life-threatening bleeding requiring urgent intervention or a need to undergo an emergency surgery/urgent invasive procedure




idebenone n/a 3/25/2004




idelalisib n/a 10/15/2013 Gilead Sciences, Inc.


idelalisib Zydelig 9/26/2013 Gilead Sciences, Inc.


Santhera Pharmaceuticals LLC

Treatment of mitochondrial myopathy, encephalopathy, lactic acidosis with stroke-like episodes syndrome (MELAS)

Santhera Pharmaceuticals Limited

Treatment of Leber's hereditary optic neuropathy.



Santhera Pharaceuticals Limited

Treatment of extranodal marginal zone lymphoma

Treatment of lymphoplasmacytic lymphoma with or without Walenstrom's macroglobulinemia




idelalisib Zydelig 10/15/2013 Gilead Sciences, Inc.




idursulfase Elaprase 11/28/2001

idursulfase IT n/a 9/3/2009

idursulfase beta n/a 2/11/2013 Green Cross Corp.

Treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma


Treatment of nodal marginal zone lymphoma.


Long term enzyme replacement therapy for patients with mucopolysaccharidosis II (Hunter Syndrome)


For treatment of neurocognitive symptoms associated with Hunter Syndrome

Shire Human Genetic Therapies

Treatment of Hunter Syndrome (mucopolysaccharidoses)



iduvec n/a 1/21/2011 Zebraic Corporation

n/a 12/13/2010

ifosfamide n/a 8/7/1985

iloprost n/a 4/6/2012 Algorithum Sciences, LLC

imatinib Gleevec 10/11/2005

imatinib mesylate n/a 5/6/2014

imatinib mesylate Gleevec 12/19/2005

imatinib mesylate Gleevec 11/1/2001

imetelstat n/a 6/11/2015

imexon Amplimexon 8/12/2005 AmpliMed Corporation

Treatment of Mucopolysaccharidosis Type I

iferanserin (S-MPEC)

For use in pulmonary arterial hypertension.

Sam Amer & Company, Inc.

Treatment of soft tissue and bone sarcomas



Treatment of Philadelphia-positive acute lymphoblastic leukemia


Treatment of progressive multifocal leukencephalopathy

Inhibikase Therapeutics, Inc.

Treatment of dermatofibrosarcoma protuberans


Treatment of gastrointestinal stromal tumors







n/a 3/2/2010 Octapharma USA, Inc.

7/20/2006

Gammaplex 4/29/2011 Bio Products Laboratory

n/a 9/10/2015 Hansa Medical AB

n/a 6/1/2015 Apitope International NV

n/a 9/4/2014

immune globulin (human)

Treatment of Guillain-Barre syndrome

immune globulin infusion (human)

Gammagard Liquid

Treatment of multifocal motor neuropathy


immune globulin intraveous (human)

Treatment of idiopathic thrombocytopenic purpura (also known as primary immune thrombocytopenia)

immunoglobulin G degrading enzyme of Streptococcus pyogenes

Prevention of antibody mediated organ rejection in solid organ transplant patients.

immunologically active synthetic peptides

Treatment of Hemophilia A

inBreath airway transplant system

To restore the structure and/or function of the trachea subsequent to tracheal damage due to cancer, injury or infection

Harvard Apparatus Regenerative Technology, Inc.



inecalcitol n/a 8/3/2015 Hybrigenics, S.A.

infliximab Remicade 11/14/1995 Centocor, Inc.

infliximab Remicade 11/12/2003 Janssen Biotech Inc.

infliximab Remicade 10/23/2002 Centocor, Inc.

n/a 2/4/2011

inolimomab Leukotac 10/23/2002 Jazz Pharmaceuticals


n/a 9/5/2008

n/a 11/4/2011 Roberto Testi, MD

Actimmune 10/1/2014


Treatment of Crohn's disease

Treatment of pediatric (0 to 16 years of age) ulcerative colitis


inhibitor of microRNA-451


miRagen Therapeutics, Inc.


inotuzumab ozogamicin

Treatment of B-cell acute lymphoblastic leukemia

insecticidal toxin derived from Bacillus thuringiensis

Treatment of soil transmitted helminth infection strongyloidiasis

University of California, San Diego

interferon gamma


interferon gamma-1b

Treatment of Friedreich's Ataxia




6/14/2012 Medgenics, Inc.

Kineret 9/15/2015

n/a 6/27/2013 Lundbeck LLC

n/a 5/28/2015 Edge Therapeutics, Inc.

iobenguane I 131 n/a 7/5/2007 Jubilant DraxImage, Inc.

Omaclear 10/21/2005

ipilimumab Yervoy 6/3/2004

interferon-alpha secreting autologous micro-organ tissue converting into a biopump

Infradure Biopump

Treatment of chronic hepatitis D

interleukin-1 receptor antagonist anakinra

Treatment of Still's disease including systemic juvenile idiopathic arithritis and adult-onset Still's disease.

Swedish Orphan Biovitrum AB

intravenous carbamazepine

Treatment of epilepsy patients who cannot take anything by mouth (NPO)

intraventricular nimodipine

Treatment of subarachnoid hemorrhage


iobenguane sulfate I-123

For the detection, localization, and staging of pheochromocytomas.

Brogan Pharmaceuticals, Inc.

Treatment of high risk Stage II, Stage III, and Stage IV melanoma

Bristol-Myers Squibb Pharmaceutical Research Insti



Radiogardase 5/1/2003

Cresemba 10/25/2013

n/a 10/20/2014

Cresemba 5/6/2013

n/a 6/9/2015


n/a 1/10/2006 Amicus Therapeutics, Inc.

isotretinoin n/a 4/10/2014

ivacaftor Kalydeco 12/20/2006

iron(III)-hexacyanoferrate(II)

Treatment of patients with known or suspected internal contamination with radioactive or non-radioactive cesium or thallium

Heyl Chemisch-Pharmzeutische Fabrik GMBH & Co, KG

isavuconazonium sulfate

Treatment of zygomycosis

Astellas Pharma Global Development Inc.


Treatment of invasive candidiasis/candidemia



Treatment of invasive aspergillosis

Astellas Pharma Global Development Inc.

isocitrate dehydrogenase 1 (IDH1)-mutant inhibitor


Agios Pharmaceuticals, Inc.

isocitrate dehydrogenase 2-mutant inhibitor


isofagomine tartrate


Treatment of congenital ichthyosis

Patagonia Pharmaceuticals, LLC

Treatment of patients with cystic fibrosis

Vertex Pharmaceuticals, Inc.



ixazomib citrate n/a 2/18/2011

ketotifen n/a 2/25/2015

n/a 1/15/2002 VSL Pharmaceuticals, Inc.



n/a 7/21/2011 Prothelia, Inc.

n/a 9/8/2011

8/25/2011

lapatinib Tykerb 5/29/2009


Millennium Pharmaceuticals


Melbourne Laboratories LLC

lactic acid bacteria (Lactobacilli, Bifidobacteria, and Steptococci)

Treatment of active chronic pouchitis

lactic acid bacteria (Lactobacilli, Bifidobacteria, and Streptococcus species)

Prevention of disease relapse in patients with chronic pouchitis

lactobacillus brevis CD2

Treatment Behcet's disease

laminin-111 (human)


lanreotide acetate

Treatment of symptoms associated with carcinoid syndrome


lanreotide acetate

Somatuline Depot



Treatment of ErbB2 positive gastric cancer




Tykerb 5/29/2009

laromustine Onrigin 10/21/2004

laronidase Aldurazyme 9/24/1997

11/25/2009 California Stem Cell, Inc.

lebrikizumab n/a 3/9/2015 Genentech, Inc.

lenalidomide Revlimid 1/17/2007 Celgene Corporation




lapatinib ditosylate hydrochloride

Treatment of ErbB2 positive esophageal cancer



Vion Pharmaceuticals, Inc.

Treatment of patients with mucopolysaccharidosis-I.


late stage human motor neutron progenitors

Motorgraft(Tm)




Treatment of myelodysplastic syndromes


Treatment of extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue






lenvatinib n/a 3/27/2014 Eisai, Inc.

lenvatinib n/a 3/26/2014 Eisai, Inc.

lenvatinib Lenvima 12/27/2012 Eisai, Inc.

lestaurtinib n/a 9/3/2009

letermovir n/a 12/12/2011





Treatment of stage IIB to Stage IV melanoma

Treatment of follicullar, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer

Treatment of Philadelphia-negative classic myeloproliferative disorders


Prevention of human cytomegalovirus viremia and disease in at risk populations

Merck Sharpe & Dhome Corporation



Multikine 5/4/2007 CEL-SCI Corporation

n/a 1/26/2015 Celtaxsys, Inc.

levetiracetam Keppra 4/30/2010 University of California

levocarnitine Carnitor 11/15/1989

levoleucovorin Fusilev 12/18/1990

leukocyte interleukin

Neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck

leukotriene A4 hydrolase inhibitor


Treatment of neonatal seizures

1. Prevention of secondary carnitine deficiency in valproic acid toxicity 2. Treatment of secondary carnitine deficiency in valproic acid toxicity


For use in combination chemotherapy with the approved agent 5-fluorouracil in the palliative treatment of metastatic adenocarcinoma of the colon and rectum




n/a 2/10/2015 Cox Biosciences LLC

n/a 4/26/2011

n/a 4/27/2015 Bio-Path Holdings, Inc.

Arikace 8/25/2009 Insmed, Inc.


levomefolate calcium

Treatment of megaloblastic anemia caused by folate deficiency

levothyroxine sodium

The preservation of organ function in brain-dead organ donors.

Fera Pharmaceuticals, LLC

liposomal P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide


liposomal amikacin

Treatment of bronchiectasis in patients with Pseudomonas aeruginosa or other susceptible microbial pathogens

liposomal amikacin

Treatment infections caused by non-tuberculous mycobacteria




Busulipo 6/24/2013 Pharmalink AB


n/a 5/11/2009 PARI Pharma GmbH

n/a 6/24/2008 PARI Pharma GmbH


n/a 11/12/2008

n/a 7/21/2011

liposomal amikacin

Treatment of bronchopulmonary Pseudomonas aeruginosa infections in cystic fibrosis patients

liposomal busulfan

For use as a conditioning regimen for patients with malignancies undergoing autologous or allogenic hematopoietic stem cell transplantation

liposomal ciprofloxacin plus ciprofloxacin

For the management of cystic fibrosis

liposomal cyclosporine

Treatment of bronchiolitis obliterans

liposomal cyclosporine for inhalation

Prevention of bronchiolitis obliterans.

liposomal encapsulated paclitaxel


liposomal gadodiamide


MedGenesis Therapeutix, Inc.

liposomal irinotecan





n/a 12/5/2003 Bio-Path, Inc.

n/a 10/30/2008

9/28/2012


n/a 10/14/2015

n/a 1/27/2015 BioRamo, LLC

n/a 9/5/2013 Aduro BioTech, Inc.

lisuride n/a 1/17/2013 Sinoxa Pharma GmbH

liposomal p-ethoxy growth receptor bound protein-2 antisense product


liposomal topotecan hydrochloride


MedGenesis Therapeutix, Inc.

liposomal Ã}Â±-galactosylceramide

Lip. Alpha Galactosylceramide

Prevention of graft-versus-host disease

REGiMMUNE Corporation

liposome encapsulated paclitaxel


lisinopril oral solution

Treatment of hypertension in pediatric patients 0 through 16 years of age.


lisinopril oral solution

Treatment of primary hypertension with complications and secondary hypertension in pediatric patients (ages 0 through 16 years of age)

listeria monocytogenes





n/a 12/13/2010 Medesis Pharma

n/a 12/20/2010 Marina Biotech



lomitapide Juxtapid 10/23/2007

lomitapide n/a 3/3/2011

lonafarnib n/a 4/18/2011

lithium citrate tetrahydrate (in reverse micelle formulation)


live attenuated E. Coli expressing Beta catenin shRNA

Treatment of Familial Adenomatous Polyposis

live attenuated bioengineered Listeria monocytogenes immunotherapy


live attenuated bioengineered Listeria monocytogenes immunotherapy

Treatment of human papilloma virus-associated head and neck cancer


Aegerion Pharmaceuticals, Inc.

Treatment of Familial Chylomicronemia


Treatment of Hutchinson-Gilford progeria syndrome

The Progeria Research Foundation, Inc.



n/a 2/27/2014 PROLOR Biotech, Ltd

losartan n/a 12/12/2011

Ibsolvmir(R) 7/6/2011 TikoMed AB

Ibsolvmir 10/20/2009 TikoMed AB

lucerastat n/a 10/29/2015

Orkambi 6/30/2014

lurbinectedin n/a 8/20/2012 PharmaMar USA, Inc.

long acting recombinantFactor VIIa-CTP3

Treatment and prophylaxis of bleeding episodes in patients with hemophilia A or B with inhibitors to factor VIII or factor IX

Treatment of Marfan Syndrome

National Marfan Foundation

low molecular weight dextran sulfate

Treatment to mobilze progenitor cells prior to stem cell transplantation

low molecular weight dextran sulfate

Prevention of graft rejection during pancreatic islet transplantation

Treatment of Fabry Disease.

Actelion Pharmaceuticals Ltd

lumacaftor/ivacaftor






n/a 5/21/2015

Thermodox (R) 3/17/2009 Celsion Corporation

n/a 9/10/2008

Asparec(Tm) 2/1/2010 Jazz Pharmaceuticals, Inc.


macitentan Opsumit 9/3/2009

lutetium (177Lu)-edotreotide

Treatment of gastro-entero-pancreatic neuroendocrine tumors

ITG Isotope Technologies Garching GmbH

lyso-thermosensitive lipsomal doxorubicin


lysosomal enzyme N-acetylgalactosamine-6-sulfate sulfatase

Treatment of mucopolysaccharidosis Type IVA (Morquio Syndrome)

Vivendy Therapeutics LTD

mPEG-r-crisantaspase

Treatment of acute lymphoblastic leukemia.

mTOR kinase inhibitor (CC-223)






n/a 9/26/2013 CMC Contrast AB

n/a 4/27/2004

maribavir n/a 6/7/2011 Shire ViroPharma, Inc.

manganese (II) chloride tetrahydrate (with L-alanine and vitamin D3 as promoters of absorption)

Use as a targeted contrast agent for diagnostic MRI for the detection and localization of focal liver lesions in patients where use of gadolinium based contrast agents may be medically inadvisable or where gadolinium based contrast agents cannot be administered

mannopentaose phosphate sulfate

Treatment of high-risk Stage II, Stage III, and Stage IV melanoma

Medigen Biotechnology Corp.

Treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients.



maribavir n/a 2/1/2007 Shire ViroPharma, Inc.

marizomib n/a 9/21/2015

masitinib n/a 4/20/2005 AB Science





n/a 7/14/2014 ImmunoGen, Inc.

Prevention of cytomegalovirus viremia and disease in the populations at risk.


Triphase Research & Development I Corp.

Treatment of malignant gastrointestinal stromal tumors


Treatment of patients with pancreatic cancer

masitinib mesylate

Treatment of gastric cancer including cancer of the gastroesophageal junction

masitinib mesylate


maytansinoid conjugated humanized monoclonal antibody against FOLRI




mebendazole 9/3/2014

mecasermin Iplex 12/3/2007 Insmed, Inc.

n/a 9/20/2012 Premacure AB

Iplex 7/23/2012 PCUT BioPartners, Inc.

Iplex 5/17/2002 Insmed, Inc.

Vermox 500 Mg Chewable Tablets

Treatment of single or mixed gastrointestinal infestations by Trichuris trichiura (whipworm), Ascaris lumbricoides (large roundworm), and Ancylostoma duodenale and Nectar americanus (hookworm).

Janssen Pharmaceutical Research & Development, LLC

Treatment of myotonic dystrophy

mecasermin rinfabate

Prevention of retinopathy of prematurity in premature infants born at risk for the disease


Treatment of amyotropic lateral sclerosis


Treatment of growth hormone insensitivity syndrome (GHIS)



Increlex 9/21/2015

meclorethamine Valchlor 8/17/2004

mefloquine HCL Lariam 4/13/1988 Hoffmann-La Roche, Inc.

n/a 9/13/2013

melatonin n/a 4/12/2013 Scharper S.p.A.

mecasermin, recombinant human insulin-like growth factor-1

Treatment of Rett Syndrome.

Keck Graduate Institute of Applied Life Sciences


Actelion Pharmaceuticals Ltd.

For use in the treatment of acute malaria due to Plasmodium falciparum and Plasmodium vivax, and for the prophylaxis of Plasmodium falciparum malaria which is resistant to other available drugs

melarsoprol-hydroxypropylbetadex

Treatment of human African trypanosomiasis (sleeping sickness)

Peter Kennedy, CBE, MD, PhD, DSc, FRCP FMedSci,

Treatment of neonatal hypoxic ischemic encephalopathy



meloxicam Mobic 11/22/2002

melphalan n/a 11/19/2012 Icon Bioscience, Inc.

melphalan n/a 7/14/2015 Delcath Systems, Inc.

melphalan n/a 11/19/2012 OncoTx, LLC

melphalan n/a 11/24/2008

n/a 3/16/2015 Oncopeptides AB

n/a 11/12/2008 Delcath Systems, Inc.





Treatment of retinoblastoma

Treatment of cholangiocarcinoma.

Treatment of Stage IIB through IV melanoma

High dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation

Spectrum Pharmaceuticals, INc.

melphalan flufenamide hydrochloride

Treatment of plasma cell myeloma, also referred to as multiple myeloma

melphalan hydrochloride

Treatment of patients with ocular (uveal) melanoma.




Treatment of patients with hepatocellular carcinoma




n/a 5/14/2014 IC-MedTech Corporation

menaquinone 9/4/2012 Nu Science Trading, LLC

menatetrenone Mk4(R) 11/2/2010 NBI Pharmaceuticals, Inc.



menatetrenone Mk4 3/17/2011 NBI Pharmaceuticals, Inc.


mepivacaine n/a 10/18/2006

mepivacaine n/a 1/8/2007

mepolizumab n/a 7/14/2011 GlaxoSmithKline LLC


Treatment of patients with cutaneous melanoma.

menadione sodium bisulfite

Treatment of autosomal dominant polycystic liver disease

Menaquinonegold


Treatment of hepatocellular carcinoma (HCC).




menatetrenone and Vitamin D3



Relmada Therapeutics, Inc.


Relmada Therapeutics, Inc.

Treatment of Churg-Strauss Syndrome.



mepolizumab n/a 5/28/2004 GlaxoSmithKline LLC

Purixan 8/20/2012

mesalamine Canasa 1/19/2010 Aptalis Pharma US, Inc.

n/a 9/10/2009

Lialda 2/27/2008 Shire

n/a 9/10/2015

Nurown 2/4/2011

For first-line treatment in patients with hypereosinophilic syndrome

mercaptopurine oral solution

Treatment of acute lymphoblastic leukemia in pediatric patients

Nova Laboratories Limited


mesalamine and N-acetycysteine

Treatment of pediatric patients with ulcerative colitis (inclusive through age 16 years)

Altheus Therapeutics, Inc.

mesalamine; 5-aminosalicylic acid

Treatment of ulcerative colitis in pediatric patients (revised indication 10/21/2010).

mesencephalic, astrocyte-derived neurotrophic factor

Treatment of retinal artery occlusion.


mesenchymal stromal cells secreting neurotrophic factors


BrainStorm Cell Therapeutics Ltd.




metadoxine n/a 12/16/2013 Alcobra, Inc.

metformin n/a 5/29/2014 EffRx Pharmaceuticals SA

methotrexate n/a 8/20/2009 Orbona Pharma Ltd

n/a 3/18/2015 Chesapeake Therapeutics

n/a 5/28/2015

met-enkephalin; Met-N



Treatment of pediatric polycystic ovary syndrome


methotrexate oral liquid formulation

Treatment of acute lymphoblastic leukemia in pediatric patients aged 0 through 16 years.

methotrexate oral solution

Treatment of acute lymphoblastic leukemia in pediatric patients (0 through 16 years of age)




n/a 8/27/2015

methoxsalen Uvadex 5/12/1994 Therakos, Inc.

methylene blue n/a 7/24/2012

n/a 8/11/2012

methotrexate oral solution

Treatment of oligoarticular juvenile idiopathic arthritis (persistent oligoarthritis, psoriatic juvenile idiopathic arthritis, enthesitis-related arthritis, or undifferentiated arthritis) and polyarticular juvenile idiopathic arthritis in children 0 through 16 years of age

Silvergate Pharmaeuticals, Inc.

For the prevention of acute rejection of cardiac allografts

Treatment of methemoglobinemia


methylene blue injection

Treatment of congenital and acquired methemoglobinemia




n/a 12/18/2012 Provepharm SAS

n/a 4/15/2013

metreleptin n/a 8/22/2001

metreleptin Myalept 8/22/2001

metronidazole n/a 9/17/2008 Avivia Project BV

metronidazole n/a 4/26/2011

metyrapone n/a 9/25/2012 Laboratoire HRA Pharma

metyrosine Demser 7/25/2008 Cerberus Princeton, LLC

mexiletine n/a 9/2/2010

methylene blue0.5%

Treatment of hereditary and acquired methemoglobinemia

methylparaben suberohydroxamic acid phenyl ester


TetraLogic Pharmaceuticals

Treatment of leptin deficiency secondary to generalized lipodystrophy and partial familial lipodystrophy

Aegerion Pharnaceuticals, Inc.

Treatment of metabolic disorders secondary to lipodystrophy


Treatment of pouchitis

Treatment of pouchitis.

S.L.A. Pharma Limited (UK)

Treatment of Cushing's syndrome

Treatment of velocardiofacial syndrome associated psychosis.

Treatment of nondystrophic myotonia

University of Rochester Medical Center



mibefradil n/a 8/25/2009 Cavion, LLC



miconazole n/a 5/22/2014 Hill Dermaceuticals, Inc.

midazolam n/a 10/20/2009

midazolam n/a 7/24/2012




Treatment of fungal otitis externa (otomycosis)

Rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity (e.g. acute repetitive seizures, seizure clusters)

Upsher-Smith Laboratories, Inc.

Treatment of nerve agent-induced seizures

Meridian Medical Technologies, Inc.



midazolam n/a 5/8/2006 UCB, Inc

mifamuritide Junovan 6/5/2001

mifepristone Korlym 7/5/2007

n/a 2/25/2004 Amicus Therapeutics, Inc.

miglustat Zavesca (R) 11/12/2008

Treatment of bouts of increased seizure activity in selected refractory patients with epilepsy who are on stable regimens of anti-epileptic drugs and who require intermittent use of midazolam



Treatment of the clinical manifestations of endogenous Cushing's syndrone

Corcept Therapeutics, Inc.

migalastat hydrochloride

Treatment of Fabry Disease

Treatment of the neurological manifestations of Niemann-Pick disease,type C.




miglustat Zavesca 5/29/1998

milatuzumab n/a 6/24/2008 Immunomedics, Inc.

milatuzumab n/a 3/10/2008 Immunomedics, Inc.

milciclib maleate n/a 9/20/2012 Tiziana Life Sciences PLC

miltefosine Impavido 10/10/2006

miltefosine 3/18/2009

mipomersen Kynamro 5/23/2006 Genzyme Corporation

Treatment of Gaucher disease.




Treatment of thymic epithelial tumors.

Treatment of leishmaniasis.

Knight Therapeutics (USA)

Miltex/Impavido

Topical treatment of cutaneous lymphoma encompassing cutaneous manifestations of T-cell lymphoma and B-cell lymphoma

ExperGen Drug Development GmbH




misoprostol Gymiso 1/10/2005

mitomycin n/a 6/1/2011 Mobius Therapeutics, LLC

mitomycin n/a 1/13/2011 Mobius Therapeutics, LLC

mitomycin Mitogel 9/8/2014 TheraCoat, Ltd.

Treatment of intrauterine fetal death not accompanied by complete expulsion of the products of conception in the second and third trimesters of pregnancy.

Gynuity Health Projects, LLC

Prevention of corneal sub-epithelial haze formation following surface ablation laser keratectomy

Prevention of recurrence of pterygium after its surgical excision.

Treatment of upper tract urothelial cell cancers (transitional cell carcinoma of the renal pelvis and ureter)



mitomycin-C Mitosol 1/8/2008 Mobius Therapeutics, LLC

mocetinostat n/a 8/7/2014 Mirati Therapeutics, Inc.

n/a 9/1/2015

n/a 4/8/2015 Aura Biosciences, Inc.

n/a 1/17/2013

n/a 5/30/2013

Treatment of refractory glaucoma as an adjunct to ab externo glaucoma surgery.


modified a-cobratoxin

Treatment of pediatric multiple sclerosis (0 through 16 years of age).

Nutra Pharma Corporation

modified human papillomavirus capsid protein conjugated to a near infrared dye

Treatment of uveal melanoma

modified recombinant human C-type natriuretic peptide (CNP)

Treatment of achondroplasia


modified recombinant human Factor VIIa (rFVIIa) molecule

Treatment of bleeding episodes in hemophilia A or B subjects with inhibitors




n/a 8/20/2012 Gencia Corporation

mogamulizumab n/a 7/14/2011



monarsen n/a 11/14/2003 Bioline Rx, Ltd.

mongersen n/a 7/20/2015 Celgene Corporation

n/a 1/21/2011 Theraclone Sciences

modified recombinant mitochondrial transcription factor A (TFAM) containing the mitochondrial transduction domain

Treatment of inherited mitochondrial respiratory chain disease

Treatment of adult T-cell leukemia/lymphoma (ATLL).

Kyowa Hakko Kirin Pharma, Inc.

Treatment of peripheral T-cell lymphoma.


Treatment of patients with cutaneous T-cell lymphoma.



Treatment of pediatric Crohn's disease

monoclonal antibody

Prevention of congential cytomegalovirus (CMV)infection following primary CMV infection in pregnant women.



n/a 12/7/2009 Alan Solomon, M.D.

n/a 12/11/2009 Alan Solomon, M.D.

n/a 10/16/2008

n/a 1/10/2014

n/a 8/25/2014 LeafBio, Inc.

n/a 11/4/2013

n/a 1/6/2015 ChemomAb, Ltd.

monoclonal antibody 11-1F4

For use as a radioimmaging agent in amyloidosis

monoclonal antibody 11-1F4

For use as a therapeutic agent for patients AL amyloidosis.

monoclonal antibody 3F8


United Therapeutics Corporation

monoclonal antibody Hu3F8



monoclonal antibody consisting of three mouse/human chimeric IgG1 monoclonal antibodies (c2G4, c4G7, and c13C6) that target Ebola virus

Treatment of Ebola virus infection

monoclonal antibody directed at hepatitis C virus E2 glycoprotein

Prevention of Hepatitis C recurrence in patients receiving liver transplantation

MassBiologics-University of MA Medical School

monoclonal antibody targeting eotaxin-2




n/a 10/29/2015 ChemomAb, Ltd.

n/a 7/29/2014

Xcytrin 1/27/2003 Pharmacyclics, Inc.

n/a 3/24/2015

n/a 9/20/2012 APEIRON Biologics AG

n/a 11/15/2007 MedImmune, LLC

monoclonal antibody targeting eotaxin-2


monomethyl auristatin E conjugated to a monoclonal antibody which targets guanylyl cyclase C



motexafin gadolinium

For use in conjunction with whole brain radiation for the treatment of brain metastases arising from solid tumors

mouse-human chimeric antibody of the IgG1 isotype, directed against human CD37

Treatment of chronic lymphocytic leukemia (CLL).


mouse-human chimeric monoclonal anti-GD2 IgG1 antibody


moxetumomab pasudotox

Treatment of CD22-positive chronic lymphocytic leukemia





moxidectin n/a 9/29/2010

M.V.I.-12 3/8/2004 Mayne Pharma (USA) Inc.

Begedina 2/18/2011 Adienne S.A.

n/a 8/20/2010


Treatment of hairy cell leukemia



Treatment of onchocerciasis volvulus in children and adults.

Medicines Development Limited

multi-vitamin infusion without vitamin K

Prevention of vitamin deficiency and thromboembolic complications in people receiving home parenteral nutrition and warfarin-type anticoagulant therapy

murine monoclonal antibody against CD26


mycobacterium vaccae

Treatment of tuberculosis

Immodulon Therapeutics Ltd



myo-inositol n/a 4/7/2005 Abbott Nutrition

nabumetone n/a 5/5/2008 Cook Pharma

naloxone n/a 11/23/2010 Elorac, Inc.

naltrexone n/a 1/19/2010 TNI BioTech, Inc.

naltrexone n/a 2/23/2015

naltrexone n/a 1/13/2015

n/a 4/14/2014

n/a 7/9/2015

Prevention of retinopathy of prematurity in preterm infants at risk for developing retinopathy of prematurity

Treatment of pediatric juvenile rheumatoid arthritis

Topical treatment of pruritus associated with mycosis fungoides

Treatment of Crohn's disease in pediatric patients


Allodynic Therapeutics LLC

Treatment of autoimmune hepatitis

TaiwanJ Pharmaceuticals Co., Ltd.

naltrexone/clonidine combination


Allodynic Therapeutics LLC

nano-diamino-tetraiodothyroacetic acid

Treatment of glioblastoma multiforme (GBM)

NanoPharmaceuticals, LLC



n/a 10/28/2015

Nanotax(R) 10/6/2015 NanOlogy, LLC

naproxcinod n/a 3/16/2015 Nicox SA


necitumumab n/a 11/20/2015 Eli Lilly and Company

nelarabine Arranon 8/10/2004

nelarabine n/a 9/2/1999

neostigmine n/a 3/18/2013

n/a 2/17/2012

nano-diamino-tetraiodothyroacetic acid


NanoPharmaceuticals, LLC

nanoparticulate paclitaxel



natural human lymphoblastoid interferon-alpha


Treatment of squamous non-small cell lung cancer

Treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma




Treatment of acute colonic pseudo-obstruction


neostigmine methylsulfate

Treatment of Myasthenia Gravis




neridronate n/a 3/25/2013 Grunenthal USA, Inc.

nevirapine n/a 11/25/2009 Auritec Pharmaceuticals

nifurtimox n/a 12/31/2013

nifurtimox Lampit 8/5/2010

nilotinib Tasigna 4/27/2006

nimodipine Nymalize 9/16/2011

nimotuzumab n/a 9/8/2015 InnoCIMab Pte Ltd

nintedanib Ofev 6/29/2011

Treatment of complex regional pain syndrome (CRPS-1, CRPS-II, CRPS-NOS)

Prevention of HIV infection in pediatric patients under the age of 16 years

Treatment of Chagas disease

MetronomX Therapeutics, LLC

Treatment of Chagas disease (American Typanosomiasis)caused by T. cruzi




Treatment of subarachnoid hemorrhage.

Arbor Pharmaceuticals, Inc.


Treatment of patients with idiopathic pulmonary fibrosis.




niprisan Hemoxin 8/15/2003

niraparib n/a 4/30/2010 TESARO, Inc.

nitazoxanide Cryptaz 10/23/2001 Romark Laboratories, L.C.

nitazoxanide Alinia 2/14/2002 Romark Laboratories, L.C.

nitric oxide Inomax (R) 9/5/2008 INO Therapeutics

nitric oxide n/a 9/23/2014

nitric oxide Inomax 12/28/2011 Bellerophon Therapeutics

nitric oxide n/a 6/18/2012 GeNO, LLC

nivolumab n/a 1/23/2013 Bristol-Myers Squibb Co.

nivolumab Opdivo(R) 9/2/2015


Xechem International, Inc.


Treatment for intestinal amebiasis

Treatment of intestinal giardiasis

Use in combination with a drug delivery device for acute treatment of sickle cell vaso-occlusive crisis (pain crises)


Advanced Inhalation Therapies Ltd.


Treatment of persistent pulmonary hypertension in newborns

Treatment of Stage IIb to IV melanoma





nivolumab n/a 9/15/2015

nivolumab n/a 8/27/2015 Bristol-Myers Squibb Co

nivolumab n/a 8/7/2014 Bristol-Myers Squibb Co.

n/a 12/15/2014 Chugai Pharma USA, LLC

At001 12/3/2014

n/a 10/20/2014

obeticholic acid n/a 4/9/2008

obinutuzumab Gazyva(R) 4/15/2015 Genentech, Inc.

Treatment of small cell lung cancer.




non-peptide small molecule orally available agonist of the parathyroid hormone receptor type I

Treatment of hypoparathyroidism

non-replicating adeno-associated viral vector, serotype 8, expressing human myotubularin gene

Treatment of x-linked myotubular myopathy

Audentes Therapeutics, Inc.

non-replicating recombinant adeno-associated virus vector containing a fragment of the gene encoding channelrhodopsin-2 protein


RetroSense Therapeutics, LLC


Intercept Pharmaceuticals, Inc.




obinutuzumab Gazyva 2/17/2012 Genentech, Inc.

obinutuzumab n/a 2/17/2012 Genentech, Inc.

obinutuzumab Gazyva 6/11/2015 Genentech, Inc.

oblimersen Genasense 7/31/2000 Genta, Inc.




octreotide Sandostatin Lar 8/5/2010

octreotide (oral) Octreolin(Tm) 6/17/2010 Chiasma, Inc.

n/a 12/7/2009


Treatment of diffuse large B cell lymphoma


Treatment of advanced malignant melanoma (Stages II,III, IV).

Treatment of acute myelocytic leukemia





For the oral treatment of acromegaly

octreotide acetate subcutaneous implant


Endo Pharmaceuticals Solutions, Inc.



ofatumumab Arzerra 3/10/2009

n/a 9/24/2001

olaparib Lynparza 10/16/2013

olaptesed pegol n/a 8/19/2014 Noxxon Pharma AG

olaratumab n/a 10/9/2014 Eli Lilly and Company

n/a 10/25/2013

n/a 2/27/2014

olipudase alfa n/a 8/3/2000 Genzyme Corporation

n/a 1/12/2009 IVAX International GmbH



oglufanide disodium


Implicit Bioscience Pty Ltd



Treatment of glioblastoma in conjunction with radiotherapy.


oleylphosphocholine

Treatment of leishmaniasis

Dafra Pharma International nv

oligopeptide containing 6 amino acids (H-Phe-Ser-Arg-Tyr-Ala-Arg-OH)


Genervon Biopharmaceuticals, LLC

Treatment of acid sphingomyelinase deficiency (Niemann-Pick disease)

omacetaine mepesuccinate




Synribo 3/10/2006 IVAX International GmbH

Viekira Pak 7/16/2015 Abbvie, Inc.

n/a 3/3/2011 Sanofi-Aventis U.S., Inc.

n/a 2/10/2015

omigapil n/a 6/24/2008

oncophage n/a 4/14/2009 Agenus, Inc.

omacetaxine mepesuccinate


ombitasvir/paritaprevir/ritonavir and dasabuvir

Treatment of pediatric patients with hepatitis C virus infection (0 through 16 years of age)

ombrabulin; N-{2-methoxy-5-[(Z)-2-(3,4,5-trimethozyphenyl)vinyl]phenyl}-L-serinamide hydrochloride


omeprazole-lansoprazoe with buffer

Treatment of esophageal ulcers

Effexus Pharmaceuticals, LLC

Treatment of congenital muscular dystrophy.


Treatment of glioma



n/a 10/14/2015

n/a 4/16/2013 Primocure Pharma, Inc.

opium tincture n/a 12/2/2011

oprozomib n/a 10/28/2014 Onyx Therapeutics, Inc.

oprozomib n/a 8/25/2014 Onyx Therapeutics, Inc.

n/a 8/20/2012

ondansetron inhalation powder

Prevention of chemotherapy-induced nausea and vomiting due to highly emetogenic chemotherapy in pediatric patients (0 through 16 years of age) .

Luxena Pharmaceuticals, Inc.

opioid growth factor

Treatment of liver and intrahepatic bile duct cancer

Treatment of chronic diarrhea in short bowel syndrome patients with an inadequate response to anti-diarrheal treatment

Valeant Pharmaceuticals International, Inc.



optically pure phenylalanine derivative

Treatment of narcolepsy

Jazz Pharmaceuticals International III Limited



n/a 1/29/2004 TRF Technologies, Inc.

osilodrostat n/a 9/13/2013

otelixizumab n/a 2/6/2006 GlaxoSmithKline

oxaloacetate n/a 7/24/2012 Terra Biological LLC

oxfendazole n/a 7/14/2014

oxybate Xyrem 11/7/1994 Jazz Pharmaceuticals

oxytocin n/a 11/24/2014 Pr Maithe Tauber

n/a 3/7/2001

n/a 5/27/2014 Array BioPharma, Inc.

oral unfractionated heparin


Treatment of Cushing's disease

Novartis Pharmaceuticals corporation

Treatment of new-onset type I diabetes mellitus


Treatment of cysticercosis (including neurocysticercosis)

Robert H. Gilman, MD, DTMH and

Treatment of narcolepsy.

Treatment of Prader-Willi syndrome

p1-(uridine 5'-)-p4-(2'-deoxycytidine 5'-) tetraphosphate, tetrasodium salt

For the treatment of cystic fibrosis

Inspire Pharmaceuticals, Inc.

p38 mitogen-activated kinase inhibitor

Treatment of dilated cardiomyopathy, including dilated cardiomyopathy secondary to lamin A/C gene mutations



paclitaxel n/a 5/1/2009 MediGene AG

Oncogel (Tm) 12/23/2008 BTG International Inc.

Oncogel(Tm) 2/1/2008 BTG International, Inc.

n/a 1/2/2013 CIRJ Co., Ltd.

Opaxio 9/20/2012

Abraxane 9/3/2009 Abraxis BioScience, LLC

Paclical 4/3/2009

n/a 7/15/2014 AcuityBio, Inc.

n/a 11/17/2006

palovarotene n/a 7/21/2014


paclitaxel aqueous gel

Treatment of brain cancer.

paclitaxel aqueous gel

Treatment of esophageal cancer

paclitaxel nanoparticles


paclitaxel poliglumex


CTI BioPharma Corporation

paclitaxel protein-bound particles


paclitaxel, micellar


Oasmia Pharmaceutical AB

paclitaxel-coated buttress

For use as local administration at the time of curative surgery in the treatment of stage 0 to III non-small cell lung cancer.

pafuramidine maleate

Treatment of pneumocystis jiroveci pneumonia


Treatment of fibrodysplasia ossificans progressiva

Clementia Pharmaceuticals, Inc.



panobinostat Farydak 8/20/2012

n/a 5/4/2015 Retrophin, Inc.

paquinimod n/a 1/17/2014 Active Biotech AB

Natpara 8/31/2007 NPS Pharmaceuticals, Inc.

paricalcitol Zemplar 10/27/2015 Abbvie, inc.

paromomycin n/a 2/11/2015

n/a 1/18/2008

pasireotide n/a 8/25/2009

pasireotide Signifor 7/24/2009



pantothenate phosphate

Treatment of pantothenate kinase associated neurodegeneration (PKAN).


parathyroid hormone


Treatment of pediatric hyperparathyroidism

Treatment of cutaneous leishmaniasis (Old World and New World)

The Surgeon General, Dept. of the Army

paromomycin sulfate/gentamicin sulfate

Treatment of all uncomplicated cutaneous leishmaniasis (both New World and Old World)

Office of the Surgeon General



Treatment of Cushing's disease




pazopanib n/a 5/6/2013

pazopanib Votrient 10/20/2009

pegargiminase n/a 7/21/2014 Polaris Group

Sylatron 4/9/2008

pegloticase Krystexxa 2/21/2001

pegsitacase Uricase-Peg 20 12/3/2009 EnzymeRx, LLC

Hepacid 3/26/1999

n/a 10/21/2010 Sangart, Inc.





Treatment of mesothelioma.

peginterferon alfa-2b

Treatment of malignant melanoma stages IIb through IV.

Schering-Plough Corporation

To control the clinical consequences of hyperuricemia in patients with severe gout in whom conventional therapy is contraindicated or has been ineffective.

Crealta Pharmaceuticals LLC

Treatment of Lesch-Nyhan syndrome.

pegylated arginine deiminase


Polaris Pharmaceuticals, Inc.

pegylated carboxyhemoglobin

Treatment of acute painful sickling crises in patients with sickle cell disease



Sanguinate 1/15/2015

n/a 4/30/2014 PharmaEssentia

n/a 3/16/2015 AERase, Inc.

n/a 4/10/2014

n/a 4/11/2014

n/a 4/2/2012

pelareorep Reolysin(R) 2/10/2015 Oncolytics Biotech, Inc.

pelareorep Reolysin 4/15/2015 Oncolytics Biotech, Inc.

pegylated carboxyhemoglobin bovine

Treatment of the comorbidities associated with Sickle Cell Disease

Prolong Pharmaceuticals, LLC

pegylated granulocyte colony stimulating factor

Treatment of patients at risk of developing myelosuppression following a radiological or nuclear incident

pegylated human recombinant arginase I

Treatment of arginase I deficiency (hyperargininemia).

pegylated proline interferon alpha-2b


PharmaEssentia, Corporation

pegylated proline interferon alpha-2b

Treatment of essential thrombocythemia

PharmaEssentia, Corporation

pegylated proline-interferon alpha-2b; PEG-P-IFNa-2b


PharmaEssentia Corporation









pembrolizumab Keytruda 6/16/2015 Merck, Sharp & Dohme

pembrolizumab Keytruda 11/19/2012

Alimta 8/28/2001 Eli Lilly and Company

pentagastrin n/a 5/29/2009

n/a 1/13/2015 CereNOva, LLC

Treatment of primary peritoneal cancer

Treatment of fallopian tube cancer



Treatment of gastric cancer, including gastroesophageal junction adenocarcinoma

Treatment of Stage IIB through IV malignant melanoma

Merck, Sharp & Dohme Corp.

pemetrexed disodium

Treatment of malignant pleural mesothelioma

To aid in the diagnosis of medullary thyroid carcinoma

Medical Defense Technologies, LLC

pentapeptide with sequence Ac-VSRRR-NH2

Treatment of intracerebral hemorrhage



4/12/2004

pentetrazol n/a 9/9/2015

n/a 11/21/2008 TRF Pharma, Inc.

Lysosan (Tm) 1/5/2015

n/a 9/16/2011

pentoxifylline n/a 6/14/2012

peptide YY n/a 4/18/2011

pentetate trisodium

Diethylenetriaminepentaacetate

Treatment of patients with known or suspected internal contamination with plutonium, americium, or curium.

Heyl Chemisch-Pharmazeutische Fabrik GMBH & Co. KG

Treatment of idiopathic hypersomnia.

Balance Therapeutics, Inc.

pentosan polysulfate sodium



Treatment of mucopolysaccharidosis (MPS) type VI

Plexcera Therapeutics, LLC



Vanguard Therapeutics, Inc.


Keck Graduate Institute of Applied Life Sciences





n/a 2/20/2009 VAXON-Biotech

n/a 9/3/2009

peptide-based vaccine targeting telomerase reverse transcriptase

Treatment of telomerase reverse transcriptase (TERT) positive non-small cell lung cancer in HLA-A*0201 positive patients

peptide-conjugated phosporodiamidate morpholino oligomer (PPMO)

Treatment of Duchenne muscular dystrophy in patients with a deletion, duplication or frame shift mutation correctable by skipping of exon 50 of the dystrophin gene to allow restoration of the reading frame (including mutations within exons 51, 51-53, or 51-55).




n/a 2/4/2011 CuraVac Europe SPRL

perampanel Fycompa 12/7/2012 Eisai, Inc.

peretinoin n/a 9/23/2011

n/a 6/14/2012

perifosine n/a 7/9/2010 Aeterna Zentaris GmbH

perillyl alcohol n/a 4/18/2011 NeOnc Technologies, Inc.

pertuzumab n/a 7/12/2013 Genentech, Inc.

pertuzumab n/a 6/8/2009 Genentech, Inc.

n/a 5/6/2013

peptides mimicking antigen receptors on autoimmune B cells and autoimmune T cells associated with myasthenia gravis


Treatment of Lennox-Gastaut Syndrome


Kowa Pharmaceutical Europe Co. Ltd.

perhexiline maleate

Treatment of moderate to severe symptomatic (NYHA class III or IV) hypertrophic cardiomyopathy

Heart Metabolics, Limited.


Treatment of glioma



pexastimogene devacirepvec


SillaJen Biotherapeutics, Inc.



n/a 10/23/2013

n/a 3/16/2015

phenylephrine n/a 2/14/2002 S.L.A. Pharma

phenylephrine n/a 1/31/2012

n/a 9/22/2008

phoxilium n/a 2/14/2014

phenobarbitol sodium injection

Treatment of hypoxic-ischemic encephalopathy to prevent siezures in neonates


phenol, 4-[2-(aminomethyl)-4-thiazolyl]-2,6-bis (1,1-dimethyethyl) monohydrochloride



Treatment of ileal pouch anal anastomosis related fecal incontinence

Treatment of Tetralogy of Fallot


phosphorothioate antisense olignucleotide against EWS-Fli-1


The Cure Our Children Foundation

For use as a replacement solution in patients undergoing continuous renal replacement therapy

Gambro Renal Products, Inc.



picibanil n/a 5/15/2009

picibanil n/a 3/17/2011 Richard Smith, M.D.

pirfenidone Esbriet 3/5/2004 Genentech

pirfenidone n/a 7/31/2014

pirfenidone n/a 11/19/2013 Genentech, Inc.

n/a 6/30/2014

plasmin (human) n/a 3/30/2009 Grifols Therapeutics, Inc.

Treatment of patients with lymphatic malformations

Royds Pharmaceuticals, Inc.

Treatment of lymphatic malformations



Genoa Pharmaceuticals, Inc.

Treatment of systemic sclerosis (including the associated interstitial lung disease)

plasmid DNA encoding the human cystic fibrosis transmembrane conductance regulator gene complexed with a nonviral cationic lipid based gene transfer agent


Imperial Innovations Limited

Treatment of acute peripheral arterial occlusion



n/a 3/5/2013

pleconaril n/a 12/22/2014

plerixafor Mozobil (R) 7/10/2003 Genzyme Corporation

polidocanol n/a 2/19/2015 Provensis Ltd

Gliadel 12/13/1989

poloxamer 188 n/a 11/8/2013 Mast Therapeutics Inc.

plasminogen (human)

Treatment of hypoplasminogenemia, or type I plasminogen deficiency

ProMetic Biotherapeutics, Inc.

Treatment of symptomatic entoviral infection in the neonate

AntiVirus Therapeutics, Inc.

For use to improve the yield of progentor cells in the apheresis product for subsequest stem cell transplantation following myelosuppressive or myeloablative chemotherapy

Treatment of congenital venous malformations

polifeprosan 20 with carmustine


Guilford Pharmaceuticals, Inc.

Treatment of Acute Limb Ischemia



n/a 6/27/1989 Mast Therapeutics Inc.

n/a 1/19/2010

n/a 10/25/2013

n/a 5/21/2015 Cerulean Pharma, Inc.

n/a 3/17/2015

Poly-Iclc 8/2/2002 Oncovir

poloxamer 188 (purified)

Treatment of sickle cell disease (this includes the treatment and prevention of complications of sickle cell disease)

poloxamer-188 NF


Phrixus Pharmaceuticals, Inc.

poly(lactide-co-glycolide) carboxylated microparticle

Treatment of acute encephalitis syndrome

Cour Pharmaceutical Development Company, Inc.

poly-CD-PEG-camptothecin


polyethylene glycol modified recombinant C-terminal truncate of human cystathionine beta-synthase

Treatment of homocystinuria

Orphan Technologies Limited

polyinosinic-polycytidilic acid

As an adjuvant to smallpox vaccination



Poly-Iclc 3/3/2003 Oncovir

Hiltonol 11/19/2002 Oncovir

polyphenon E n/a 7/17/2008 Mitsui Norin Co., Ltd

pomalidomide Pomalyst 1/15/2003 Celgene Corporation

pomalidomide n/a 9/21/2010 Celgene Corporation

polyinosinic-polycytidilic acid

Treatment of flavivirus infections including those due to West Nile, Japanese encephalitis, dengue, St. Louis encephalitis, yellow fever, Murray valley, and Banzai viruses

polyinosinic-polycytidilic acid (Poly-ICLC)

Treatment for orthopox virus infections



Treatment of persons with myeloproliferative neoplasm-associated myelofibrosis and anemia who are red blood cell tranfusion dependent.



ponatinib Iclusig(R) 3/12/2015

ponatinib Iclusig 11/20/2009

ponatinib Iclusig 11/20/2009

n/a 12/3/2012

porfimer Photofrin 10/19/2001 Axcan Scandipharm Inc.

n/a 1/8/2007

Treatment of gastrointestinal stromal tumors (GIST).

ARIAD Pharmaceuticals, Inc.

Treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL)

ARIAD Pharmaceuticals Inc.


ARIAD Pharmaceuticals Inc.

porcine GM1 ganglioside


TRB Chemedica International S.A.

For the ablation of High-Grade Dysplasia in Barrett's Esophagus in patients who are not considered to be candidates for esophagectomy

potassium sodium aluminosilicate

For treatment of poisoning by or exposure to cesium.

Framework Therapeutics, LLC



pracinostat n/a 2/27/2014 MEI Pharma Inc.

pralatrexate Folotyn 7/20/2006 Allos Therapeutics, Inc.

pralatrexate n/a 5/3/2010 Allos Therapeutics, Inc.



n/a 10/18/2012

pramipexole Mirapex 1/31/2008

Effient 5/26/2015 Eli Lilly

pritumumab n/a 10/28/2014 Nascent Biotech, Inc.

n/a 7/23/2015 Vanquish Oncology, Inc.

Treatment of acute myeloid leulemia

Treatment of T-cell lymphoma

Treatment of advanced or metastatic transitional cell carcinoma of the urinary bladder



pralmorelin hydrochloride

As a diagnostic agent for the detection of growth hormone deficiency

Sella Pharmaceuticals, Inc.

Treatment of Tourette's syndrome in pediatric patients

Boehringer-Ingelheim Pharmaceuticals, Inc.

prasugrel hydrochloride


Treatment of glioma

procaspase-activating compound 1




profimer sodium Photofrin(R) 12/2/2011

progesterone n/a 12/22/1994 Watson Laboratories, Inc.

Prolanta 4/15/2013 Oncolix, Inc.

propranolol Hemangeol 9/5/2008

n/a 7/8/2015 Vicus Therapeutics, LLC




Concordia Laboratories, Inc.

Establishment and maintenance of pregnancy in women undergoing in vitro fertilization or embryo transfer procedures.

prolactin receptor antagonist


Treatment of proliferating infantile hemangiomas requiring systemic therapy

Pierre Fabre Dermatologie

propranolol and etodolac


propranolol and etodolac


propranolol hydrochloride and etodolac




Kcentra 12/27/2012 CSL Behring

n/a 9/1/2015 TxCell SA

n/a 4/27/2009 ImmuneWorks, Inc.


pyrimethamine n/a 8/16/2011 ExSAR Corporation

pyrvinium n/a 1/5/2015

prothrombin complex concentrate (human)

Treatment of patients needing urgent reversal of Vitamin K antagonist therapy for treatment of major bleeding and/or surgical procedures

purified autologous type 1 regulatory T lymphocytes specific for human type II collagen

Treatment of chronic non-infectious uveitis

purified bovine type collagen


pyridoxine; vitamin B6

Treatment of pyridoxine dependent seizures.

Treatment of GM-2 gangliosidoses (Tay-Sachs disease and Sandhoff disease).


StemSynergy Therapeutics, Inc.



quinacrine n/a 9/28/2012

quinine Sulfate n/a 6/3/2004

quinine sulfate n/a 12/2/2008

n/a 2/11/2005

Venticute 4/3/2000

rSP-C surfactant Venticute 9/18/2006 Altana Pharma


Cleveland BioLabs, Inc & Incuron, LLC Joint Ventur


AR Holding Company, Inc.

Treatment of malaria excluding Plasmodium faliparum

Zydus Pharmaceuticals, Inc.

rAAV2-CB-hRPE65

Treatment of type II Leber's Congential Amaurosis

Applied Genetic Technologies Corp.

rSP-C lung surfactant

Treatment of adult respiratory distress syndrome.

Byk Gulden Pharmaceuticals

For use in patients with pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation, and severe oxygen impairment



rVIIa-FP n/a 12/22/2011 CSL Behring

12/31/2013 RadioMedix, Inc.

raloxifene Evista 7/14/2005 Eli Lilly and Company

Evista 8/20/2010

ramucirumab n/a 11/4/2011 Eli Lilly and Company

ramucirumab Cyramza 2/16/2012 Eli Lilly and Company

Glionix(Tm) 5/29/2009 NovaRx Corporation

ranprinase Onconase 1/25/2007 Alfacell Corporation

Treatment and prophyllaxis of bleeding episodes in patients with congenital hemophilia and inhibitors to coagulation factor VIII or IX

radiolabeled somastatin analog

Galiomedix(Tm)

Diagnostic for the management of neuroendocrine tumors

Reduction of the risk of breast cancer in postmenopausal women

raloxifene hydrochloride

Treatment of hereditary hemorrhagic telangiectasia

Consejo Superior de Investigaciones Cientificas



ranagengliotucel-L

Treatment of astrocytic tumors




rasburicase Elitek 10/11/2000

raxibacumab Abthraxtm 11/12/2003

n/a 4/29/2014 Abeona Therapeutics

n/a 1/31/2014 Scancell Ltd.

n/a 4/18/2011


n/a 3/25/2013

Treatment of malignancy-associated or chemotherapy-induced hyperuricemia.

Sanofi-Synthelabo Research

Treatment of anthrax

Human Genome Sciences, Inc.

recombinant AAV9 expressing human sulfoglucosamine sulfohydrolase

Treatment of mucopolysaccharidosis type III-A (Sanfilippo Syndrome Type A)

recombinant DNA plasmid

Treatment of stage IIb, IIc, III and IV melanoma.

recombinant IgA protease of bacterium Heamophilus influenzae

Treatment of immunoglobulin A nephropathy (IgAN, Berger's disease).

Shire Human Genetics Therapies

recombinant activated Factor X variant

Treatment of intracerebral hemorrhage

recombinant adeno- associated virus vector AAV2/rh8 expressing human B-hexosaminidase A and B subunits

For the treatment of Sandhoff disease

Nat'l Tay-Sachs & Allied Diseases Association



Raav-Aat 1/27/2003

n/a 8/25/2009 Neurologix, Inc.

n/a 10/29/2015

recombinant adeno-associated virus alpha 1-antitrypsin vector

Treatment of alpha1-antitrypsin deficiency


recombinant adeno-associated virus encoded gene for X-linked mammalian inhibitor of apoptosis protein (XIAP)


recombinant adeno-associated virus serotype 9 vector containing the transgene UBE3A encoding for ubiquitin protein ligase E3A/E6-AP

Treatment of Angelman Syndrome.

Agilis Biotherapeutics, LLC



n/a 6/16/2015

n/a 11/16/2015

n/a 2/4/2011

recombinant adeno-associated virus serotype rhesus 74 (rh74) expressing the human CT GalNac transferase (GALGT2) gene, also called the Sda or Cad GAlNac transferase or b4Galnt2, under control of the muscle creatine kinase (MCK) promoter


Nationwide Children's Hospital

recombinant adeno-associated virus vector expressing the cyclic nucleotide gated channel alpha subunit (CNGA3)

Treatment of achromatopsia caused by mutations in the CNGA3 gene


recombinant adeno-associated virus vector expressing the cyclic nucleotide gated channel beta subunit (rAAV-CNGB3)

Treatment of achromatopsia caused by mutations in the CNGB3 gene.




n/a 3/25/2013

Anthim 6/9/2006 Elusys Therapeutics, Inc.

Cethrin 11/18/2005

n/a 3/18/2013 Proteo Biotech AG

n/a 10/7/2015


recombinant adenovirus vector AAV2/rh8 expressing human B-hexosaminidase A & B subunits

Treatment of Tay-Sachs disease

Na't Tay-Sachs & Allied Diseases Association

recombinant chimeric monoclonal antibody to anthrax

Treatment of exposure to B. anthracis spores

recombinant deriative of C3 transferase


Vertex Pharmaceuticals, Inc.

recombinant elafin

Prevention of inflammatory complications of transthoracic esophagectomy

recombinant fusion protein comprising exenatide and XTEN

Treatment of short bowel syndrome.

NAIA Pharmaceuticals, Inc.

recombinant fusion protein consisiting of a modified form of extracellular domain of human Activin receptor IIB





n/a 4/27/2012 CSL Behring, LLC

n/a 5/6/2013 CSL Behring

Proxinium 1/28/2005 Viventia Biotech, Inc.

recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB (ActRIIB) linked to a human IgG1 Fc domain

Treatment of B-thalassemia

recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)

Treatment of patients with congenital factor IX deficiency (hemophilia B).

recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP)

Treatment of congenital factor VII deficiency which includes treatment and prophylaxis of bleeding episodes in patients with congenital factor VII deficiency

recombinant fusion protein with a truncated form of the cytotoxic protein Pseudomonas exotoxin

Treatment of Ep-CAM-positive squamous cell carcinoma of the head and neck



n/a 8/20/2010

n/a 6/9/2015 OncoImmune, Inc.

n/a 10/31/2012 Serendex ApS

n/a 12/14/2009

n/a 3/5/2013

n/a 8/26/2014 Promedior, Inc.

recombinant glycosylated independent lysosomal targeting (GILT) tagged human acid alpha glucosidase

Treatment of Pompe disease.


recombinant human CD24FcIg (humanized fusion protein consisting of the extracellular domain of CD24 linked to IgG1 Fc domain

Prevention of graft-versus-host disease

recombinant human GM-CSF, molgramostim

Treatment of pulmonary alveolar proteinosis

recombinant human IgG1 monoclonal antibody

Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets)

Ultragenyx Pharmaceutical, Inc.

recombinant human Naglu- insulin-like growth factor II

Treatment of mucopolysaccharidosis type IIIB (Sanfilippo syndrome type B)


recombinant human Pentraxin-2




n/a 2/17/2012 Promedior, Inc.

Plexcerase(Tm) 12/24/2013

n/a 5/13/2015 AM-Pharma BV

n/a 11/20/2001 AiroMedica LLC

n/a 3/6/1998

n/a 8/28/2001 AiroMedica LLC

n/a 4/15/2013 Alexion Pharmaceuticals

recombinant human Pentraxin-2; recombinant human Serum Amyloid P


recombinant human acid ceramidase

Treatment of Faber disease

Plexcera Therapeutics, LLC

recombinant human alkaline phosphatase

Treatment of hypophosphatasia.

recombinant human alpha 1-antitrypsin (rAAT)


recombinant human alpha-1 antitrypsin


PPL Therapeutics (Scotland) Limited

recombinant human alpha-1 antitrypsin (rAAT)

To delay progression of chronic obstructive pulmonary disease resulting from AAT deficiency-mediated emphysema and bronchiectasis

recombinant human alpha-N-acetylglucosaminidase

Treatment of mucopolysaccharidosis IIIB (Sanfilippo B syndrome)



n/a 11/19/2013


Atryn 12/7/2007 GTC Biotherapeutics, Inc.

n/a 2/16/2012

n/a 3/17/2014

recombinant human alpha-glucosidase conjugated with synthetic bis-mannose-6-phosphate-Man6 glycan

Treatment of Pompe Disease

Genzyme, a Sanofi Company

recombinant human anti-GDF-8 monoclonal antibody


recombinant human antithrombin

Treatment of congenital antithrombin deficiency to prevent the occurrence of serious, potentially life-threatening venous thromboembolisms which may develop as a result of surgical or obstetrical procedures

recombinant human beta-glucuronidase

Treatment of mucopolysaccharidosis VII (MPS VII, Sly Syndrome)


recombinant human collagen alpha-1 (VII) chain homo-trimer (rC7)

Treatment of dystrophic epidermolysis bullosa




n/a 8/18/2014 SciVac Ltd.

n/a 8/18/2014 SciVac Ltd.


n/a 5/26/2011

n/a 1/27/2015 TargaZyme, Inc.

Galaczym 12/12/2011 ACE BioSciences A/S

n/a 12/3/2012 Jade Therapeutics LLC

recombinant human deoxyribonuclease I

Treatment of graft-vs-host disease

recombinant human deoxyribonuclease I (DNase I)

Prevention of graft-vs-host disease

recombinant human endostatin protein


recombinant human erythropoietin (rHuEPO)

Treatment of mutliple myeloma

XTL Biopharmaceuticals, Ltd

recombinant human fucosyltransferase VI [ FTVI ] + GDP-fucose

To increase the activity of regulatory T-cells (Tregs) used in the prevention of graft versus host disease in patients undergoing hematopoietic stem cell transplantation

recombinant human galactocerebrosidase (rhGALC);

Treatment of globoid cell leukodystrophy (Krabbe Disease)

recombinant human gowth hormone in an ocular delivery system

Treatment of persistent corneal epithelial defects



n/a 4/22/2015 aTyr Pharma, Inc.

Oncohist 10/20/2008 Xenetic Biosciences Plc

n/a 9/2/2010 AlphaCore Pharma, LLC

Mubodina(R) 6/7/2011 Adienne S.A

Mubodina 2/4/2009 Adienne S.A.

recombinant human histidyl tRNA synthetase

Treatment of facioscapulohumeral muscular dystrophy

recombinant human histone H1.3; recombinant human N-bis-met-histone H1.3


recombinant human lecithin:cholesterol acyltransferase (rhLCAT)

Treatment of LCAT deficiency syndromes

recombinant human minibody against complement component

Treatment of atypical hemolytic uremic syndrome associated with an inherited abnormality of the complement system.

recombinant human minibody against complement component C5

Treatment of primary membranoproliferative glomerulonephritis



n/a 2/4/2009 Adienne S.A.


n/a 10/25/2013 Patrys Ltd.

n/a 6/18/2012

recombinant human minibody against complement component C5 fused with RGD-motif

Prevention of ischemia/reperfusion injury associated with solid organ transplantation.

recombinant human monoclonal IgG1 antibody against programmed death ligand-1 (anti-PD-L1)

Treatment of merkel cell carcinoma.

recombinant human monoclonal IgM antibody targeting glucose regulated protein 78


recombinant human monoclonal antibody against activin receptors type II

Treatment of inclusion body myositis




n/a 8/19/2014

Mycograb 9/16/2002

n/a 8/8/2013 Dompe s.p.a.

n/a 6/23/2014 Dompe s.p.a.

n/a 12/9/2003 Dyax Corporation

n/a 8/6/2010

Porphozyme 9/9/2002 Zymenex A/S

n/a 7/11/2002 Zymenex A/S

recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor

Treatment of pigmented villonodular synovitis, including giant cell tumor of the tendon sheath

Novartis Pharmaceuticals Corp

recombinant human monoclonal antibody to hsp90

Treatment of invasive candidiasis


recombinant human nerve growth factor


recombinant human nerve growth factor

Treatment of neurotrophic keratitis

recombinant human neutrophil inhibitor (hNE)


recombinant human platelet derived growth factor-BB

Treatment of osteochondritis dissecans

Biomimetic Therapeutics, Inc.

recombinant human porphobilinogen deaminase

Treatment of acute intermittent porphyria attacks

recombinant human porphobilinogen deaminase, erythropoetic form

Treatment of acute intermittent porphyria preventing attacks



n/a 12/10/2008

n/a 6/23/2014 Airway Therapeutics LLC

n/a 4/1/2013

n/a 4/3/2009

n/a 6/18/2008

n/a 6/7/2010 NeuroNova AB

recombinant human proinsulin (Including rhPI-Methionine)


ProRetina Therapeutics, S.L.

recombinant human surfactant protein D


recombinant human tripeptidyl-peptidase 1 (rhTPP1)

Treatment of neuronal ceroid lipofuscinosis type 2


recombinant human type I pancreatic elastase

Prevention of arteriovenous fistula and arteriovenous graft failure in patients with chronic kidney disease (CKD) who are receiving hemodialysis or preparing for hemodialysis

Proteon Therapeutics, Inc.

recombinant human type VII collagen

Treatment of hereditary dystrophic epidermolysis bullosa (DEB)

David T. Woodley, MD and Mei Chen, MD

recombinant human vascular endothelial growth factor




n/a 4/12/2013 NKT Therapeutics, Inc.

n/a 2/11/2015 Receptos, Inc.


n/a 1/22/2015 C2N Diagnostics, LLC


n/a 11/23/2010 Dermadis SA

recombinant humanized IgG1k monoclonal antibody to human invariant T cell receptor (iTCR)


recombinant humanized anti-interleukin 13 (IL-13) monoclonal antibody

Treatment of eosinophilic esophagitis

recombinant humanized anti-matrix metalloprotein 9 (MMP9) monoclonal antibody IgG4


recombinant humanized anti-tau antibody

Treatment of progressive supranuclear palsy

recombinant humanized monoclonal antibody of the immunoglobulin G1 subclass directed against colony stimulating factor-1 receptor expressed on macrophages

Treatment of pigmented villonodular synovitis and tenosynovial giant cell tumor

recombinant kallikrein inhibitor

Treatment of Netherton Syndrome.



n/a 5/19/2014 Ocugen, Inc.

n/a 2/10/2015


n/a 12/8/2014 ARCA Biopharma, Inc.

n/a 11/17/2014 University of Pittsburgh

Tauferon 1/25/2005 PEPGEN Corporation

recombinant lens epithelium derived growth factor 1-326


recombinant monoclonal antibody to human serum amyloid P component

Treatment of AL amyloidosis

Glaxo Group Limited, England d/b/a GlaxoSmithKline

recombinant multimerized human IgG1 Fc

Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

recombinant nematode anticoagulant protein c2 (rNAPc2)

Treatment of viral hemorrhagic fever post-exposure to Ebola virus (treatment of Ebola)

recombinant neuroglobin (rNgb) containing mutations H64Q/C46G/C55S/C120S

Treatment of patients with carbon monoxide poisoning

recombinant ovine interferon tau

Treatment of pediatric multiple sclerosis



n/a 12/13/2010

n/a 11/23/2010 Baxalta, Inc.

n/a 3/19/2015

refanalin n/a 5/25/2010

regorafenib Stivarga 1/12/2011

regorafenib Stivarga 6/4/2015

reparixin n/a 9/25/2012 Dompe S.p.A.

recombinant thymidine phosphorylase encapsulated with autologous erythrocytes

Treatment of mitochondrial neurogastrointestinal encephalomyopathydue to thymidine phosphorylase deficiency.

St. George's University of London

recombinant von Willebrand factor (rhVWF)

Treatment of von Willebrand disease.

reduced oxidized N-acetyl heparin


Sigma-Tau Research Switerland S.A.

To improve renal function and prevent delayed graft function following renal transplantation

Angion Biomedica Corporation

Treatment gastrointestinal stromal tumors




Prevention of graft loss in pancreatic islet transplantation



reparixin n/a 1/27/2003 Dompe S.p.A.

n/a 5/3/2013 John A. Chiorini, PhD

H.P. Acthar Gel 6/28/2013

H.P. Acthar Gel 5/21/2003

resiniferatoxin n/a 5/13/2003

reslizumab Cinquil 1/12/2011

reslizumab n/a 12/19/2007 TEVA

resminostat n/a 9/16/2011 4SC AG

Prevention of delayed graft function in solid organ transplant

replication-deficient recombinant serotype 2 adeno-associated viral vector containing hAQP1 cDNA

Treatment of symptoms of Grade 2 and Grade 3 late xerostomia from parotid gland hypofunction caused by radiotherapy for cancer of the oral cavity.

repository corticortropin injection


Questor Pharmaceuticals, Inc.

repository corticotropin or adrenocorticotropic hormone


Questcor Pharmaceuticals, Inc.

Treatment of intractable pain at end-stage disease

Sorrento Theraeputics, Inc.

Treatment of hypereosinophilic syndrome

Teva Pharmaceuticals, Inc.

Treatment of children with eosinophilic esophagitis

Treatment of Hodgkin's lymphoma.



resminostat n/a 6/29/2011 4SC AG

n/a 4/29/2002 AVAX technologies, Inc.

revusiran n/a 5/18/2015

Jetrea 3/16/2004 ThromboGenics Inc.

rhIGF-I/rhIGFBP-3 Somatokine 12/9/2003 Insmed, Inc.

ribavirin Virazole 4/12/1991

ribavirin Rebetol 4/4/2003 Schering Corporation


retroviral gamma-c cDNA containing vector

Treatment of X linked severe combined immune deficiency disease

Treatment of transthyretin amyloidosis

Alnylam Pharmaceuticals, Inc.

rh-microplasmin, ocriplasmin

Adjunct to surgery in cases of pediatric vitrectomy

Treatment of extreme insulin resistance syndromes (type A, Rabson-Mendenhall syndrome, Leprechaunism, Type B syndrome)

Treatment of hemorrhagic fever with renal syndrome

Valeant Pharmaceuticals International

Treatment of chronic hepatitis C in pediatric patients



ribavirin elaidate n/a 9/2/2011

n/a 9/2/2011 Avedro, Inc.

n/a 12/2/2011 Avedro, Inc.

ricin vaccine Rivax(R) 1/7/2011 Soligenix, Inc.

rifaximin Normix 2/10/1998

rigosertib n/a 3/16/2012



Treatment of follicular, medullary, and anaplastic thyroid carcinoma and metastatic or locally advanced papillary thyroid cancer

Translational Therapeutics, Inc.

riboflavin ophthalmic solution & ultraviolet A

Treatment of keratoconus

riboflavin ophthalmic solution ultraviolet-A (UVA) irradiation

Treatment of corneal ectasia following refractive surgery

Prevention of ricin intoxication.

Treatment of hepatic encephalopathy

Salix Pharmaceuticals, Inc.




Onconova Therapeutics, Inc





rilonacept Arcalyst 1/9/2013

rilotumumab n/a 6/18/2012 Amgen, Inc.

rindopepimut n/a 11/19/2007 Celldex Therapeutics, Inc.

riociguat Adempas 9/19/2013



rituximab Rituxan 6/13/1994 Genentech, Inc.


Treatment of familial Mediterranean fever

Philip J Hashkes, MD, MSc.

Treatment of gastric cancer including gastroesophageal junction adenocarcinoma

Treatment of EGFRvIII-expressing glioblastoma multiforme




Bayer HealthCare Pharmaceuticals

Treatment of chronic thromboembolic pulmonary hypertension


Treatment of non-Hodgkin's B-cell lymphoma





rituximab 2/23/2015 Genentech, Inc.


rociletinib n/a 5/14/2013 Clovis Oncology, Inc.

rofecoxib Vioxx 3/16/2004 MERCK & Co., Inc.

romidepsin Istodax 9/30/2004 Celgene Corporation


Rituxan(R); Mabthera(R)

Treatment of pemphigus vulgaris.

Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome)

Treatment of non-small cell lung cancer and mutations in the epidermal growth factor receptor


Treatment of non-Hodgkin T-cell lymphomas



romiplostim Nplate 3/27/2003 Amgen, Inc.

romiplostim n/a 10/31/2007 Amgen Inc.

rosuvastatin Crestor 2/14/2014

rozrolimupab n/a 9/13/2010 Symphogen A/S

rsATP7A cDNA n/a 1/10/2014 Stephen G. Kaler, MD

rt-PA Activase 10/20/2014

rubitecan n/a 7/17/2002 SuperGen, Inc.


Treatment of thrombocytopenia associated with myelodysplasia syndrome

For the treatment of pediatric homozygous familial hypercholesterolemia


Treatment of primary immune thrombocytopenia.

Treatment of Menkes disease

Treatment of plastic bronchitis

Kathleen A Stringer, PharmD, FCCP - Professor

Treatment of pediatric patients infected with human immunodeficiency virus and acquired immunodeficiency syndrome



rucaparib n/a 7/31/2012 Clovis Oncology, Inc.

rufinamide Banzel 10/8/2004 Eisai, Inc.

ruxolitinib Jakafi 8/16/2013 Incyte Corporation

ruxolitinib Jakafi 3/26/2010 Incyte Corporation

Jakafi 9/5/2008 Incyte Corporation

Jakafi 3/22/2010 Incyte Corporation



salicylic acid 6% n/a 2/17/2012 Orenova Group, LLC

salirasib n/a 12/18/2006 Kadmon Corporation, LLC

n/a 10/29/2009 Lithera, Inc.


Treatment of Lennox-Gastaut Syndrome.



ruxolitinib phosphate


ruxolitinib phosphate

Treatment of essential thrombocythemia

sacituzumab govitecan


sacituzumab govitecan


Treatment of rare congenital ichthyoses.


salmeterol xinafoate/fluticasone propionate

Treatment of symptomatic exophthalmos associated with thyroid related eye disease



saposin C n/a 2/3/2015

sapropterin Kuvan 1/29/2004

sarcosine n/a 10/12/2011

sarizotan n/a 7/7/2015

n/a 4/15/2013 TransDerm, Inc.

sebelipase alfa n/a 7/1/2010

n/a 9/5/2013 BioLineRx, Ltd.


Bexion Pharmaceuticals, LLC



Treatment of obsessive compulsive disorder in pediatric patients (0 to 16 years of age)

Guochuan Emil Tsai, MD, PhD

Treatment of Rett syndrome.

Newron Pharmaceuticals US, Inc.

sdTD-K6a.513a.12; small interfering RNA composed of 2 strands of hybridized RNAs


Treatment of lysosomal acid lipase deficiency

Synageva BioPharma Corp.

selective antagonist of the chemokine receptor type 4




n/a 3/28/2011

n/a 8/19/2014

selexipag n/a 4/30/2010 Actelion Ltd

n/a 9/27/2013 Hannah's Hope Fund

selinexor n/a 1/5/2015

selisistat n/a 12/7/2009 Siena Biotech SpA

selumetinib n/a 4/15/2015

selective deacylglycerol acyltransferase 1 inhibitor

Treatment of hypertriglyceridemia in te setting of Type I hyperlipoproteinemia, also known as Familial Chylomicronemia Syndrome


selective inhibitor of fungal lanosterol demethylase

Treatment of cryptococcal meningitis

Viamet Pharmaceuticals, Inc.


self-complimentary adeno-associated virus vector, serotype 9, packaging the full lenght GAN gene in the viral capsid

Treatment of Giant Axonal Neuropathy




Treatment of uveal melanoma.




setmelanotide n/a 9/21/2015 Rhythm Metabolics, Inc.

sevuparin n/a 3/17/2015 Dilaforette AB

sialic acid n/a 9/23/2011

sildenafil Revatio 7/28/2011 Pfizer, Inc.

Legalon(R) Sil 9/11/2014

siltuximab Sylvant 5/26/2006 Janssen Biotech, Inc.

simtuzumab n/a 1/5/2015 Gilead Sciences, Inc.

Treatment of Prader-Willi Syndrome.


Treatment of hereditary inclusion body myopathy.


Treatment of pediatric (defined as children less than 17 years of age) pulmonary arterial hypertension

silibinin-C-2',3-dihydrogensuccinate, disodium salt

Treatment of amatoxin poisoning, which includes the prevention and treatment of amatoxin induced hepatic failure

Meda Pharmaceuticals, Inc.

Treatment of Castleman's disease




n/a 7/17/2014

siponimod n/a 7/10/2014

sirolimus n/a 11/17/2011

sirolimus n/a 6/25/2014 LAM Therapeutics, Inc.

sirolimus Rapamune 10/31/2012 Pfizer, Inc.

sirolimus n/a 3/18/2013 TransDerm, Inc.

single stranded, chemically modified oligonucleotide that binds to and inhibits the function of micro RNA-21

Treatment of Alport syndrome

Regulus Therapeutics, Inc.



Treatment of lymphangioleiomyomatosis

Cote Orphan Consulting, LLC






sirolimus n/a 11/4/2011 Santen Inc.

Coll-R, Sirogen 5/10/2012 Vascular Therapies, LLC

Cerepro 7/31/2001

Treatment of chronic/refractory anterior noninfectious uveitis, noninfectious intermediate uveitis, noninfectious panuveitis and non-infectious, uveitis affecting the posterior of the eye (NICUPS).

sirolimus in an implantable collagen matrix

Prevention of arteriovenous(AV) fistula or AV graft failure in patients with end stage renal disease, receiving hemodialysis or preparing for hemodialysis

sitimagene ceradenovec

Use with gancyclovir in the treatment of malignant glioma

Finvector Vision Therapies Ltd



skin tissue Stratagraft 5/21/2012 Stratatech Corporation

n/a 9/14/2015

n/a 8/15/2013 Epizyme Inc.

n/a 8/8/2013 Epizyme Inc.

n/a 9/26/2013 Omeros Corporation

n/a 6/12/2014

smilagenin Cogane 7/21/2011 Junaxo, Inc.

Treatment of hospitalized patients with complex skin defects resulting from partial and full thickness skin burns requiring excision and grafting

small molecule FGFR4 inhibitor

Treatment of hepatocellular cancer (HCC).

Blueprint Medicines Corporation

small molecule inhibitor of histone methyltransferase DOT1L

Treatment of Acute Myeloid Leukemia

small molecule inhibitor of histone methyltransferase DOT1L

Treatment of acute lymphoblastic leukemia (ALL)

small molecule inhibitor of phosphodiesterase 10


small molecule normalizing the p53 function


Critical Outcome Technologies, Inc.




sobetirome n/a 4/29/2011 NeuroVia, Inc.

n/a 7/25/2008

n/a 8/25/2015

n/a 10/18/2011 GMP-Orphan SAS

n/a 4/3/2009

Apatone(R) 4/15/2013 IC-Medtech Corporation



Treatment of X-linked adrenoleukodystrophy

sodium 2, 2 dimethylbutyrate


HemaQuest Pharmaceuticals, Inc.

sodium 2-hydroxylinoleate


Ability Pharmaceuticals, SL

sodium 4-phenylbutyrate


sodium 4-{ [9-chloro-7-(2-fluoro-6-methoxyphenyl)-5H-pyrimido [5,4-d] [2] benzazepin-2-yl]-2-methoxybenzoate



sodium ascorbate and menadione sodium bisulfite

Treatment of autosomal dominant polycystic liver disease


Treatment of noninfected painful total joint without mechanical complication


Treatment of autosomal dominant polycystic kidney disease



n/a 12/22/2011

sodium chlorite n/a 8/22/2011

n/a 7/3/2003 EBD Group

n/a 11/29/2010

sodium fusidate n/a 10/23/2013

sodium nitrite n/a 7/8/2008

sodium benzoate and clozapine

Treatment of treatment-resistant schizophrenia

Guochuan Emil Tsai, MD, PhD

For slowing the progression of amyotrophic lateral sclerosis.

Neuraltus Pharmaceuticals, Inc.

sodium dichloroacetate

Use as an antidote in the management of systemic monochloroacetic acid poisoning

sodium dichloroacetate

For pulmonary arterial hypertension.

Peter W. Stackpoole, PhD, MD

Treatment of patients with prosthetic joint infections

Cempra Pharmaceuticals, Inc.


Airess Pharmaceuticals, Inc.



sodium nitrite n/a 9/3/2009 Hope Pharmaceuticals

sodium nitrite n/a 1/9/2012 Hope Pharmaceuticals

n/a 11/10/2015 Arch Biopartners, Inc.

Nithiodote 4/9/2008 Hope Pharmaceuticals

Buphenyl 11/22/1993

Prevention of ischemia reperfusion injury to donor organ tissue associated with solid organ transplantation

Treatment of chlorine gas poisoning

sodium nitrite and EDTA

Treatment of Pseudomonas aeruginosa pulmonary infections in patients with cystic fibrosis

sodium nitrite and sodium thiosulfate

Treatment of known or suspected cyanide poisoning

sodium phenylbutyrate

Treatment of urea cycle disorders: carbamylphosphate synthetase deficiency, ornithine transcarbamylase deficiency, and arginiosuccinic acid synthetase deficiency.




n/a 7/2/1992

Pheburane 6/6/2013 Lucane Pharma SA

n/a 1/19/2010 Navinta LLC

n/a 8/19/2014 Acer Therapeutics, Inc.

n/a 10/28/2009

Suprep 10/31/2012


Treatment for sickling disorders, which include S-S hemoglobinopathy, S-C hemoglobinopathy, and S-thalassemia hemoglobinopathy.





Treatment of urea cycle disorder.


Treatment of maple syrup urine disease

sodium stibogluconate

Treatment of cutaneous leishmaniasis

Surgeon General of the US Army

sodium sulfate, potassium sulfate, and magnesium sulfate

For cleansing of the colon in preparation for colonoscopic diagnosis of colonic disease in children and adolescents

Braintree Laboratories, Inc.



Suclear 9/4/2013

n/a 12/2/2010 Hope Pharmaceuticals



n/a 11/19/2012 Edinburg BioQuarter



sodium valproate n/a 8/5/2015

sodium sulfate, potassium sulfate, and magnesium sulfate; PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride

For use in cleansing of the colon in preparation for colonoscopy in children and adolescents

Braintree Laboratories, Inc.

sodium thiosulfate

Treatment of extravasation of meclorethamine hydrochloride into subcutaneous tissues.

sodium thiosulfate

Treatment of uremic and non-uremic calciphylaxis

sodium thiosulfate

Prevention of platinum-induced ototoxicity in pediatric patients

sodium thiosulfate


sodium thiosulfate

Treatment of sulfur mustard poisoning

sodium thiosulfate


Treatment of Wolfram syndrome

The University of Birmingham



Uniplas 12/12/2005 Octapharma USA, Inc.

somatorelin Somatrel 8/8/1989 Ferring Laboratories, Inc.

Genotropin 12/27/2000

sonidegib n/a 3/23/2015

sorafenib Nexavar 12/12/2011

solvent/detergent treated non-blood-group specific human coagulation active plasma


Diagnostic measure of the capacity of the pituitary gland to release growth hormone.

somatropin [rDNA]

Treatment of growth failure in children who were born small for gestational age.

Pharmacia and Upjohn Company

Treatment of medulloblastoma


Treatment of medullary thyroid cancer, anaplastic thyroid cancer, and recurrent or metastatic follicular or papillary thyroid cancer




sotalol (IV) So-Aqueous 7/25/2008

n/a 2/10/2014

sotatercept n/a 12/5/2013 Celgene Corporation

sotatercept n/a 4/28/2014 Celgene Corporation

For ventricular tachycardia, ventricular fibrillation, or the maintenance of sinus rhythm in patients converted from atrial fibrillation or atrial flutter when oral administration is not possible.

Academic Pharmaceuticals

sotalol hydrochloride

Treatment of life-threatening ventricular arrhythmias in pediatric patients

Arbor Pharmaceuticals, LLC

Treatment of beta-thalassemia intermedia and major

Treatment of anemias associated with myelodysplastic syndrome and myelodysplastic/myeloproliferative neoplasms.



sparsentan n/a 1/5/2015 Retrophin, LLC

n/a 12/19/2007 Ocera Therapeutics, Inc.

spironolactone Aldactone 5/22/2014 CMP Pharma, Inc.

n/a 5/11/2001 Genaera Corporation

n/a 6/10/2015 Protalex, Inc.

Nicord(R) 11/13/2014 Gamida Cell Ltd.


Treatment of Focal Segmental Glomerulosclerosis

spherical carbon adsorbent

Treatment of chronic pouchitis

Use in pediatric patients with primary hyperaldosteronism

squalamine lactate

Treatment of ovarian cancer refractory or resistant to standard chemotherapy

staphylococcal aureus protein A


stem/progenitor cells derived from ex vivo expanded allogeneic umbilical cord blood cells



Treatment of Hodgkin lymphoma.




stiripentol Diacomit 10/30/2008 Biocodex

sulfamidase n/a 5/22/2008

n/a 2/17/2012

sulthiame n/a 7/25/2013

Etr019 4/30/2010 Verius Limited


Treatment of acute lymphoblastic leukemia.

Treatment of Dravet syndrome

For treatment of Sanfilippo Syndrome (MPS IIIA)


sulfonated monophosphorylated mannose oligosaccharide


Medigen Biotechnology Corporation

Treatment of patients with benign epilepsy of childhood with centrotemporal spikes (BECTS) also known as rolandic epilepsy


superoxide dismutase, gliadin




n/a 6/4/2014

n/a 4/22/2015

n/a 8/16/2013 Alnylam Pharmaceuticals

n/a 8/12/2013 Alnylam Pharmaceuticals

n/a 12/23/2009

synthetic 14-mer phosphorothioate antisense oligonucleotide directed against TGF-beta2 mRNA

Prevention of scarring post glaucoma filtration surgery

Isarna Therapeutics GmbH

synthetic double-stranded (hybridized duplex) ribonucleic acid oligonucleotide specific to hydroxyacid oxidase 1 gene

Treatment of primary hyperoxaluria type 1

Dicerna Pharmaceuticals, Inc.

synthetic double-stranded siRNA oligonucleotide against antithrombin (AT) mRNA


synthetic double-stranded siRNA oligonucleotide against antithrombin mRNA


synthetic double-stranded siRNA oligonucleotide against p53 mRNA

Prophylaxis of delayed graft function in renal transplant patients

Quark Pharmaceuticals, Inc.



n/a 6/14/2012


n/a 10/12/2011 Atox Bio, Inc.

n/a 1/16/2013

n/a 6/16/2015

n/a 3/16/2012 Chiesi USA, Inc.

tabalumab n/a 11/19/2012 Eli Lilly and Company

synthetic double-stranded siRNA oligonucleotide against transthyretin (TTR) mRNA

Treatment of familial amyloidotic polyneuropathy

Alnylam Pharmaceuticals, Inc.

synthetic oligomer of 16 nucleotides

Treatment of myotonic dystrophy Type I

synthetic peptide H-D-Ala-Ser-Pro-Met-Leu-Val-Ala-Tyr-Asp-D-Ala-OH

Treatment of necrotizing soft tissue infections (NSTI)

synthetic peptide; cyclo-Cys-Gly-Gln-Arg-Glu-Thr-Pro-Glu-Gly-Ala-Glu-ALA-Lys-Pro-Trp-Tyr-Cys

Treatment of high altitude pulmonary edema

Apeptico Forschung und Entwicklung GmbH

synthetic signal peptide of human mucin-1 (amino acids 1-21)


Vaxil Bio Therapeutics Ltd.

synthetic surfactant comprised of DPPC, POPG Na, synthetic SP-C analogue and synthetic SP-B analogue

Treatment of preterm neonatal respiratory distress syndrome




Trinam 10/24/2000

tacrolimus n/a 3/16/2015 Selten Pharma, Inc.

tacrolimus n/a 5/4/2015

tacrolimus n/a 7/6/2012

tacrolimus Envarsus Xr 12/20/2013

tadalafil Adcirca 12/18/2006 Eli Lilly and Company

tadalafil 5/4/2015 Eli Lilly and Company

taberminogene vadenovec

Prevention of complications due to neointimal hyperplasia disease in certain vascular anastomoses.

Finvector Vision Therapies, Ltd.



Stanford University School of Medicine

Treatment of hemorrhagic cystitis

Lipella Pharmaceuticals Inc.

Prophylaxis of organ rejection in patients receiving allogeneic kidney transplant

Veloxis Pharmaceuticals, Inc.


Cialis(R); Adcirca(R)

Treatment of Duchenne Muscular Dystrophy (DMD)



tafamidis n/a 5/23/2006 Pfizer, Inc.


tafenoquine n/a 1/15/2013

talactoferrin alfa n/a 8/20/2003 Agennix, Inc.

talactoferrin alfa n/a 8/20/2003 Agennix, Inc.

talarazole n/a 3/16/2012 Stiefel Laboratories, Inc.

n/a 3/14/2011

tarextumab n/a 1/26/2015

tarextumab n/a 1/26/2015

Treatment of familial amyloid polyneuropathy

tafamidis meglumine

Treatment of symptomatic transthyretin (TTR) amyloid cardiomyopathy.


Glaxo Group Limited, England

For the prevention of graft-versus-host disease

For the treatment of graft versus host disease


talimogene laherparepvec

Treatment of stage IIb-stage IV melanoma

BioVex, Inc. (subsidiary of Amgen)







tasimelteon n/a 4/30/2010

tasimelteon Hetlioz 1/19/2010

taurine n/a 3/22/2010

Lymphoseek 9/17/2014

Treatment of sleep-wake disorder in Smith-Magenis syndrome associated with diurnal melatonin secretion

Vanda Pharmaceuticals, Inc.

Non-24-hour sleepwake disorder in blind individuals without light perception

Vanda Pharmaceuticals, Inc.

Treatment of cystathionine beta-synthase deficient homocystinuria

Johan L. Van Hove, MD, PhD

technetium Tc 99m tilmanocept

Use in sentinel lymph node detection (SLN) with a hand-held gamma-counter, with scintigraphic imaging, in patients with cancer of the head and neck

Navidea Biopharmaceuticals



tecovirimat n/a 12/18/2006 SIGA Technologies, Inc.



Gattex 6/29/2000 NPS Pharmaceuticals, Inc.

telatinib n/a 5/17/2010 ACT Biotech Inc.

temocillin sodium Negaban 4/21/2004 Belpharma S.A.

temozolomide Temodar 10/5/1998

temozolomide n/a 11/25/2015

tenofovir Viread 3/17/2009 Gilead Sciences, Inc.

teprotumumab n/a 5/6/2013 River Vision, Inc.

terguride 5/17/2013 Serodapharm UG

post exposure prophylaxis against smallpox

Treatment of smallpox.

Treatment of orthopoxvirus infections.

teduglutide [rDNA origin]

Treatment of short bowel syndrome.


Treatment of pulmonary infections caused by Burkholderia cepacia

Treatment of recurrent malignant glioma.


Treatment glioblastoma multiforme in pediatric patients

AmpliPharm Pharmaceuticals, LLC

Treatment of pediatric HIV infection.

Treatment of active (dynamic) phase Grave's orbitopathy

Mysalfon, Teluron




teriparatide Forteo 4/18/2014 Entera Bio, Ltd.

terlipressin n/a 10/29/2004 Ikaria (INO Therapeutics)

tesetaxel n/a 12/22/2008 Genta Inc.

tesetaxel n/a 11/21/2008 Genta, Inc.

n/a 2/13/2013 SOV Therapeutics, Inc.

n/a 1/17/2014

n/a 3/16/2015 Aeolus Pharmaceuticals


Treatment of Hepatorenal Syndrome


Treatment of stages IIB, IIC, III, and stage IV melanoma

testosterone undecanoate (oral)

Treatment of constitutional delay in growth and puberty in adolescent boys (14-17 yrs of age)

tetra substituted prophyrin derivative containing manganese (III)

For use in patients exposed to radiation following a nuclear accident or detonation in order to treat or mitigate acute radiation syndrome.

Aeolus Pharmaceuticals, Inc.

tetra-substituted porphyrin derivative containing manganese (III)




tetrabenazine n/a 7/1/2009

10/31/2012

thalidomide n/a 9/19/1988

n/a 12/8/2014

Kevetrin 11/17/2015 Cellceutix Corporation

Kevetrin 7/14/2015 Cellceutix Corporation

Treatment of Tourette's Syndrome in school-age children, ages 5-16

Valeant International (Barbados) SRL

tetracosactide hexaacetate (beta 1-24-corticotrophin)

Synacthen Depot, S. Retard


Cerium Pharmaceuticals, Inc.

1. Treatment of graft versus host disease in patients receiving bone marrow transplantation 2. Prevention of graft versus host disease in patients receiving bone marrow transplantation

Pediatric Pharmaceuticals, Inc.

theranost 68Ga-RGD

Diagnostic for clinical management of patients with neuroblastoma


thioureidobutyronitrile

Treatment of retinoblastoma.

thioureidobutyronitrile




thymopentin n/a 2/4/2011

thymosin beta 4 n/a 12/31/2013 ReGenTree, LLC

tigecycline n/a 10/23/2013

n/a 11/4/2003

tinidazole Tindamax 4/18/2002 Presutti Laboratories, Inc.

tipelukast n/a 10/20/2014 MediciNova, Inc.

tiprelestat Elafin 12/28/2012 Proteo Biotech AG

n/a 8/20/2012 Debiopharm

tirapazamine n/a 10/23/2002 Sanofi-Aventis US, Inc.

tirasemtiv n/a 3/2/2010 Cytokinetics Inc.

tisagenlecleucel-T n/a 2/3/2015

Treatment of sarcoidosis.


Treatment of patients with neurotrophic keratopathy


Trillium Therapeutics, Inc.

tin ethyl etiopurpurin

Prevention of access graft disease in hemodialysis patients

Miravant Medical Technologies

Treatment of giardiasis



tiptorelin pamoate


Treatment of head and neck cancer

Treatment of amyotrophic lateral sclerosis (ALS)





tivantinib n/a 10/16/2013

tocilizumab Actemra 4/17/2013 Genentech, Inc.

tocilizumab Actemra 7/31/2012 Genentech, Inc.

tolerogen n/a 2/5/2015 Toleranzia AB

tolvaptan Samsca 4/6/2012

Treatment of hepatocelular carcinoma

Daiichi Sankyo Pharma Development


Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis


Treatment of autosomal dominant polycystic kidney disease

Otsuka Pharmaceuticals Co., Ltd.



n/a 7/24/2013

trabectedin Yondelis 3/29/2005

trabectedin Yondelis 9/30/2004

trabedersen Oncomun 6/5/2002

trabedersen n/a 8/22/2011

trabedersen n/a 7/21/2009

tralokinumab n/a 7/24/2012 MedImmune Ltd.

topiramate injection

Treatment of partial onset or primary generalized tonic-clonic seizures for hospitalized epilepsy patients or epilepsy patients being treated in an emergency care setting who are unable to take oral topiramate

CURx Pharmaceuticals, Inc.

Treatment of patients with ovarian cancer






Treatment of Stage IIB through Stage IV malignant melanoma.







trametinib Mekinist 12/20/2010

9/20/2012

tranilast Rizaben 12/23/2010 Altacor Ltd

n/a 7/21/2011

n/a 12/3/2012



trastuzumab Herceptin 12/14/1999 Genentech, Inc.

Treatment of Stage IIb through Stage IV melanoma


trametinib and dabrafenib

Mekinist And Tafinlar

Treatment of Stage IIb through IV melanoma.


Prevention of scarring following glaucoma filtration surgery

trans sodium crocetinate

Treatment of glioblastoma in conjunction with radiotherapy

Diffusion Pharmaceuticals, LLC

trans sodium crocetinate

Treatment of brain metastasis

Diffusion Pharmaceuticals, LLC

transforming growth factor-beta receptor 1 kinase inhibitor

Treatment of glioma

transforming growth factor-beta receptor 1 kinase inhibitor


Treatment of patients with pancreatic cancer that overexpress p185HER2.



trastuzumab Herceptin 10/13/2009 Genentech, Inc.

10/25/2013 Genethech, Inc.

trebananib n/a 8/30/2013 Amgen, Inc.

trehalose Cabaletta 10/25/2013 BIOBLAST PHARMA LTD.

trehalose n/a 11/17/2014 BioBlast Pharma Ltd

tremelimumab n/a 3/18/2015 MedImmune, LLC

Treatment of HER2-overexpressing advanced adenocarcinoma of the stomach, including gastroesophageal junction

trastuzumab emtansine

Kadcyla Ã¿Æ¿Ã¿Â¿¿Ã¿Â¢Ã¢Â¿¿Â¬Ã¿Â¡Ã¿Æ¿Ã¢Â¿¬Å¡Ã¿Â¿¿Ã¿Â®

For the treatment of gastric cancer including gastroesophageal junction cancer.


Treatment of occulopharyngeal muscular dystrophy

Treatment of spinal cerebellar ataxia type 3 (also known as SCA3 or Machado Joseph disease)




tremelimumab n/a 9/18/2006 MedImmune

treosulfan n/a 4/8/2015 Medac GmbH

treprostinil Remodulin 6/4/1997

Tyvaso 6/17/2010 LungRx, Inc.

n/a 11/23/2001 Cell Works Inc.

triciribine n/a 2/1/2008

Syprine(R) 11/2/2010 Cerberus Princeton, LLC

Treatment of stage IIb to stage IV metastatic melanoma

Conditioning treatment prior to hematopoietic stem cell transplantation (HSCT) in malignant and non-malignant diseases in adults and pediatric patients.


United Therapeutics Corp.

treprostinil (inhalational)


tri-antennary glycotripeptide derivative of 5-fluorodeoxyuridine monophosphate

Treatment for hepatocellular carcinoma


VioQuest Pharmaceuticals, Inc.

trientine hydrochloride

Treatment of manganism.



trifarotene n/a 6/6/2014 Galderma R&D, LLC

triheptanoin n/a 10/21/2014

triheptanoin n/a 4/15/2015

n/a 7/23/2014 Avicin Therapeutics, Ltd.

n/a 3/9/2012

n/a 6/9/2015 Lion Biotechnologies, Inc.

ubenimex n/a 11/19/2015

ubiquinol 4/12/2004

ublituximab n/a 8/6/2010 TG Therapeutics, Inc.


Treatment of glucose transporter type-1 deficiency syndrome


Treatment of fatty acid oxidation disorders


triterpenoid saponin


tryptophan hydroxylase (TPH) inhibitor

Management of symptoms of carcinoid syndrome associated with carcinoid tumor

Lexicon Pharmaceuticals, Inc.

tumor-inflitrating lymphocytes; LN-144

Treatment of malignant melanoma Stages IIb to IV


Eiger BioPharmaceuticals, Inc.

Ubi-Q-Nol, Li-Q-Nol


Gel-Tec, Division of Tishcon Corp.






udenafil n/a 8/31/2015 Mezzion Pharma Co. Ltd.

ulocuplumab n/a 1/12/2015

Rescula 9/16/2010 R-Tech Ueno, Ltd.

Treatment of Extranodal marginal zone lymphoma (mucosa-associated lymphatic tissue, MALT)

Treatment of Nodal marginal zone lymphoma

Treatment of single ventricle congenital heart disease with Fontan physiology



unoprostone isopropyl




urea n/a 11/7/2011 Orenova Group, LLC

uridine triacetate n/a 5/1/2009



Treatment of rare congenital ichthyoses (CHILD syndrome, collodion baby, congenital ichthyosform erythroderma, Conradi-flunermann, epidermolytic hyperkeratosis, erythrokeratoderma variabilis, harlequin ichthyosis, KID syndrome, lamellar ichthyosis, Netherton syndrome, neutral lipid storage disease, Sjorgren-Larsson syndrome, trichothiodystrophy, X-linked ichthyosis).

An antidote in the treatment of 5-fluorouracil poisoning

Wellstat Therapeutics Corp.

Treatment of mitchondrial disease

Wellstat Therapeutics Corporation

Treatment of hereditary orotic aciduria

Wellstat Therapeutics, Inc.



ursodiol 10/23/2007

ustekinumab Stelara 11/29/2010

n/a 11/10/2015 Seattle Genetics, Inc.

n/a 5/21/2007

n/a 10/28/2015 Carmel Biosciences

vancomycin n/a 12/27/2012

n/a 9/20/2012

Ursofalk Suspension

Treatment of cystic fibrosis liver disease

Asklepion Pharmaceuticals, LLC

Treatment of type 1 diabetes mellitus patients with residual beta-cell function.

Johnson & Johnson Pharmaceutical & Development LLC

vadastuximab talirine


valine-valine-ganciclovir

Treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to HSV1 and HSV2.

Verenta Pharmaceuticals, Inc.

valsartan oral solution

Treatment of hypertension in pediatric patients 0 through 16 years of age

Treatment of endophthalmitis


vancomycin hydrochloride (inhalational)

Treatment of persistent methicillin-resistant S. aureus lung infection in patients with cystic fibrosis

Savara Pharmaceuticals, Inc.



vandetanib Caprelsa(R) 10/21/2005

vapreotide Octastatin 1/10/2000 Debiopharm S.A.

vapreotide Sanvar 1/10/2000 Debiovision, Inc.

vapreotide Octastatin 3/6/2000 Debiopharm S.A.

vapreotide Sanvar 11/4/2003 H3 Pharma, Inc.

Treatment of patients with follicular thyroid carcinoma, medullary thyroid carcinoma, anaplastic thyroid carcinoma, and locally advanced and metastatic papillary thyroid carcinoma

AstraZeneca Pharmaceutical LP

Treatment of gastrointestinal and pancreatic fistulas.

Treatment of esophageal variceal hemorrhage patients with portal hypertension.

Prevention of early postoperative complications following pancreatic resection.




n/a 6/24/2008 PhiloGene, Inc.

n/a 5/13/2014

vatiquinone Vincerinone 6/4/2014



Vpriv 6/8/2009

veliparib n/a 12/17/2014 AbbVie Inc.

veliparib n/a 5/9/2008 AbbVie, Inc.

vascular endothelial growth factor 165b

Treatment of advanced melanoma stages IIb through IV.

vasoactive intestinal peptide (VIP)-elastin-like peptide (ELP) fusion protein

Treatment of pulmonary arterial hypertension, WHO Group 1

PhaseBio Pharmaceuticals, Inc.

Treatment of Leigh Syndrome

Edison Pharmaceuticals, Inc.





velaglucerase-alfa


Shire Human Genetics Therapies, Inc.

Treatment of brain metastases when used in combination with DNA-damaging agents

Treatment of glioblastoma multiforme when used in combination with DNA-damaging agents





veltuzumab n/a 11/17/2014 Immunomedics, Inc.



vemurafenib Zelboraf 11/26/2013 Genentech, Inc.

Treatment of hepatocellular carcinoma in combination with DNA-damaging agents

Treatment of epithelial ovarian cancer in combination with DNA-damaging agents

Treatment of pemphigus



Treatment of anaplastic thyroid carcinoma and advanced papillary thyroid cancer whose tumors harbor a BRAF V600 mutation




vemurafenib Zelboraf 12/20/2010 Hoffmann-La Roche, Inc.


verteporfin Visudyne(R) 3/9/2012

vibriolysin Vibrilase 6/16/2006

vigabatrin Sabril 6/12/2000 H. Lundbeck A/S

Marqibo 1/8/2007 Talon Therapeutics, Inc.

Treatment of hairy cell leukemia (HCL).

Treatment of patients with IIb to Stage IV melanoma positive for the BRAF(v600) mutation

Treatment of patients with non-small cell lung cancer (NSCLC) with BRAF V600E mutation

Treatment of chronic or recurrent central serous chorioretinopathy

Valeant Pharmaceuticals North America LLC

Debridement of severe, deep dermal burns in hospitalized patients

BioMarin Pharmaceutical Inc.


vinCRIStine sulfate LIPOSOME injection




Marqibo 6/24/2008 Talon Therapeutics

vintafolide n/a 12/16/2013 Endocyte, Inc.

n/a 7/14/2015 Advent Therapeutics, Inc.


volasertib n/a 4/14/2014

Wilfactin 5/29/2014 rEVO Biologics, Inc.

vorinostat Zolinza 3/16/2004 Merck & Co., Inc.

vosaroxin n/a 10/28/2009

xenon gas n/a 5/18/2015 Neuroprotexeon

vincristine sulfate liposomes

Treatment of metastatic uveal melanoma.


vitamin A palmitate

Prevention of bronchopulmonary dysplasia.

volanesorsen sodium, apolipotrotein C-III antisense oligonucleotide

treatment of familial chylomicronemia syndrome



von Willebrand Factor Human Concentrate

Treatment of Von Willebrand Disease



Sunesis Pharmaceuticals, Inc.

To improve neurological outcome in hospitalized cardiac arrest patients.



xenon gas n/a 12/3/2014 Neuroprotexeon

zidovudine Retrovir 7/17/1985 Glaxo Wellcome Inc.

n/a 4/15/2015 Thar Pharmaceuticals

zoledronic acid 5/6/2013

n/a 4/10/2014

Dysport(R) 12/5/1991

Nicord 4/28/2014 Gamida Cell Ltd

Treatment of hypoxic ischemic encephalopathy

Treatment of AIDS

zoledronate D,L-lysine monohydrate (ZLM)

Treatment of complex regional pain syndrome (CRPS)

Zometa, Reclast, Aclasta

Treatment of complex regional pain syndrome (CRPS).

Axsome Therapeutics, Inc.

{2-amino-8-[4-(pyrrolidinylcarbonyl)phenyl](3H-benzo[f]azepin-4-yl)}-N,N-dipropycarboxamide


VentiRx Pharmaceuticals, Inc.

Treatment of essential blepharospasm.


For the treatment of acute myeloid leukemia



Biothrax 4/11/2014

For post-exposure prophylaxis of anthrax disease resulting from suspected or confirmed Bacillus anthracis exposure

Emergent Product Development Gaithersburg, Inc.

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