Download pdf - 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Transcript

Page 1: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209637Orig1s000

PRODUCT QUALITY REVIEW(S)

Page 2: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Page 3: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Page 4: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Page 5: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Page 6: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Page 7: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Page 8: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Page 9: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Page 10: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Page 11: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Page 12: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Page 13: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

ElizabethBearr

Digitally signed by Elizabeth Bearr

Date: 7/25/2017 10:11:34AM

GUID: 55370d1e00cfd67fc04d8bfbedbf3096

ErikaPfeiler

Digitally signed by Erika Pfeiler

Date: 7/25/2017 10:12:40AM

GUID: 502d1da500002b6a73a00c0e0dff6e1d

Page 14: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Page 15: 209637Orig1s000 - accessdata.fda.gov€¦ · liraglutide (an approved product ... not include testing for biological activity because the assay method by HPLC is ... Phannaceutical

Su (Suong)Tran

Digitally signed by Su (Suong) Tran

Date: 7/27/2017 04:13:30PM

GUID: 508da71f00029ec8b75e233f12b15339

Recommended

Jan 03, 2014 · Ethyl Acetate n-Butyl Acetate Acetone N-Methyl-2-pyrrolidone Tetrahydrofuran Tetrahydrofuran Ethyl Ether Methyl t-Butyl Ether Grade HPLC HPLC HPLC HPLC HPLC HPLC

Jan 03, 2014 · Ethyl Acetate n-Butyl Acetate Acetone N-Methyl-2-pyrrolidone Tetrahydrofuran Tetrahydrofuran Ethyl Ether Methyl t-Butyl Ether Grade HPLC HPLC HPLC HPLC HPLC HPLC Documents

Is Xultophy (insulin degludec/liraglutide) a match … › __media › ...Xultophy® Insulin degludec and Liraglutide. Please consult the full Summary of Product Characteristics (SmPC)

Is Xultophy (insulin degludec/liraglutide) a match … › __media › ...Xultophy® Insulin degludec and Liraglutide. Please consult the full Summary of Product Characteristics (SmPC) Documents

Liraglutide for the treatment of diabetes mellitus in Japan...blood glucose (area under the curve [AUC] glucose, 0–24h /24) in patients receiving liraglutide was 20% lower in the

Liraglutide for the treatment of diabetes mellitus in Japan...blood glucose (area under the curve [AUC] glucose, 0–24h /24) in patients receiving liraglutide was 20% lower in the Documents

203791Orig1s000 - accessdata.fda.gov

203791Orig1s000 - accessdata.fda.gov Documents

ABCD Nationwide Exenatide and Liraglutide Audits · ABCD Nationwide Exenatide and Liraglutide Audits Dr Bob Ryder and Professor Stephen Gough on behalf of the ABCD nationwide exenatide

ABCD Nationwide Exenatide and Liraglutide Audits · ABCD Nationwide Exenatide and Liraglutide Audits Dr Bob Ryder and Professor Stephen Gough on behalf of the ABCD nationwide exenatide Documents

Plus CBD Oil™...Product name original spray peppermint WL Batch/Lot#: 7219316W Strength: 20z 500mg Analyst: VK AUG 23 2017 Method: HPLC HPLC HPLC HPLC HPLC HPLC HPLC HPLC HPLC mg:

Plus CBD Oil™...Product name original spray peppermint WL Batch/Lot#: 7219316W Strength: 20z 500mg Analyst: VK AUG 23 2017 Method: HPLC HPLC HPLC HPLC HPLC HPLC HPLC HPLC HPLC mg: Documents

The Glucagon-Like Peptide-1 Receptor Agonist Liraglutide

The Glucagon-Like Peptide-1 Receptor Agonist Liraglutide Documents

Original Article MicroRNA profile changes in liraglutide ...Original Article MicroRNA profile changes in liraglutide treated steatotic HepG2 cells Yunfeng Shen 1,2, Meimei Liu , Chao Documents

Divergent Effects of Liraglutide, Exendin-4, and

Divergent Effects of Liraglutide, Exendin-4, and Documents

liraglutide and sitagliptin in experimentally model of NF

liraglutide and sitagliptin in experimentally model of NF Documents

Capillary HPLC Introduction Capillary HPLC Liquid chromatography

Capillary HPLC Introduction Capillary HPLC Liquid chromatography Documents

Liraglutide protects from renal damage via Akt-mTOR pathway in … · 2019-08-07 · 117 Abstract. – OBJECTIVE: To explore the pro- tective effect of liraglutide on renal damage

Liraglutide protects from renal damage via Akt-mTOR pathway in … · 2019-08-07 · 117 Abstract. – OBJECTIVE: To explore the pro- tective effect of liraglutide on renal damage Documents

HPLC SYSTEM S 500 SERIES - Sykamsykam.com/wp-content/uploads/HPLC-System-S500-web.pdf · The Sykam HPLC System S 500 Series ... analytical tasks in HPLC and GPC. S 1125 HPLC PUMP

HPLC SYSTEM S 500 SERIES - Sykamsykam.com/wp-content/uploads/HPLC-System-S500-web.pdf · The Sykam HPLC System S 500 Series ... analytical tasks in HPLC and GPC. S 1125 HPLC PUMP Documents

Attachment: Product Information: Liraglutide...Attachment 1: Product information AusPAR VICTOZA, SAXENDA liraglutide Novo Nordisk Pharmaceuticals Pty. Ltd. -PM-2016-003931-1-5 -FINAL

Attachment: Product Information: Liraglutide...Attachment 1: Product information AusPAR VICTOZA, SAXENDA liraglutide Novo Nordisk Pharmaceuticals Pty. Ltd. -PM-2016-003931-1-5 -FINAL Documents

A Randomized, Controlled Trial of Liraglutide for Adolescents with … · 2020. 6. 19. · Liraglutide may be useful for weight management in adolescents with obesity. METHODS In

A Randomized, Controlled Trial of Liraglutide for Adolescents with … · 2020. 6. 19. · Liraglutide may be useful for weight management in adolescents with obesity. METHODS In Documents

Victoza (Liraglutide) Solution for Injection - PAXpress

Victoza (Liraglutide) Solution for Injection - PAXpress Documents

LEADER: Liraglutide VICTOZA CV Outcomes Trial Summary · RXFILES TRIAL SUMMARY JULY 2016; UPDATED MAY 2017 – Page 1 of 3 LEADER: Liraglutide VICTOZA CV Outcomes Trial Summary1 Liraglutide:

LEADER: Liraglutide VICTOZA CV Outcomes Trial Summary · RXFILES TRIAL SUMMARY JULY 2016; UPDATED MAY 2017 – Page 1 of 3 LEADER: Liraglutide VICTOZA CV Outcomes Trial Summary1 Liraglutide: Documents

The Sweetness of Pharmacotherapy · 2020. 8. 10. · CV Effects ASCVD: benefit in liraglutide>semaglutide>exenatide ER HF: Neutral Renal Dosing Progression of DKD: Benefit: liraglutide

The Sweetness of Pharmacotherapy · 2020. 8. 10. · CV Effects ASCVD: benefit in liraglutide>semaglutide>exenatide ER HF: Neutral Renal Dosing Progression of DKD: Benefit: liraglutide Documents