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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209589Orig1s000 PRODUCT QUALITY REVIEW(S)

209589Orig1s000 - accessdata.fda.gov · memorandum department of health and human services public health service food and drug administration center for drug evaluation and research

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Page 1: 209589Orig1s000 - accessdata.fda.gov · memorandum department of health and human services public health service food and drug administration center for drug evaluation and research

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209589Orig1s000

PRODUCT QUALITY REVIEW(S)

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HamidShafiei

Digitally signed by Hamid ShafieiDate: 10/13/2017 03:59:44PMGUID: 507d824300005f344cf8b5e5989f0057

Moo JhongRhee

Digitally signed by Moo Jhong RheeDate: 10/13/2017 04:11:17PMGUID: 502d0913000029f9798ca689a802fa55

Reference ID: 4188796Reference ID: 4188796

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Memorandum DEPARTMENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICEFOOD AND DRUG ADMINISTRATIONCENTER FOR DRUG EVALUATION AND RESEARCH

Date: October 25, 2017From: Hamid Shafiei, Ph.D.

Drug Product Reviewer, Branch VDivision of New Drug Products IIOffice of New Drug Products

Through: Moo-Jhong Rhee, Ph.D.Chief, Branch VDivision of New Drug Products IIOffice of New Drug Products

To: CMC Label/Labeling Review #1 of NDA 209589

Subject: Review of the Resubmitted Immediate Container and Carton Labels

During the Review # 1 of the label/labeling of NDA 209589 for Clenpiq (sodium picosulfate, magnesium oxide, anhydrous citric acid Oral Solution, 10mg/3.5g/12g, the following deficiencies were noted:

1) Immediate container label: • The font size of the established name should be at least 50% of the

tradename and also it should be as prominent as the tradename.

• Add lot number and expiration date

• Add bar code.

2) Carton label:• The font size of the established name should be at least 50% of the

tradename and also it should be as prominent as the tradename.

• Add lot number and expiration date to the carton label.

In an amendment dated October 25, 2017, the applicant has resubmitted revised immediate container and carton labels. The labels are presented in Figures 1 and 2.

Reference ID: 4188796Reference ID: 4188796

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2

Figure 1: Immediate Container (Bottle) Label

Reference ID: 4188796Reference ID: 4188796

(b) (4)

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3

Review Comments and Evaluation

Lot number, expiration date, and bar code have been added to the immediate container label. The font size and prominence of established name vs trade name have been appropriately addressed.

Lot number and expiration date have been added to the carton label. The font size and prominence of the established name vs trade name have been appropriately addressed.

Recommendation:

The resubmitted immediate container (bottle) and carton labels are deemed satisfactory from the ONDP perspective. All label/labeling deficiencies have been adequately addressed. This application is now recommended for approval from the label/labeling standpoint.

Hamid R. Shafiei, Ph.D.Drug Product Reviewer Branch V, Division II, ONDP

Moo-Jhong Rhee, Ph.D.Chief, Branch V, Division II, ONDP

Reference ID: 4188796Reference ID: 4188796

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HamidShafiei

Digitally signed by Hamid ShafieiDate: 10/25/2017 03:34:21PMGUID: 507d824300005f344cf8b5e5989f0057

Moo JhongRhee

Digitally signed by Moo Jhong RheeDate: 10/25/2017 03:38:11PMGUID: 502d0913000029f9798ca689a802fa55

Reference ID: 4188796Reference ID: 4188796

37 Page(s) have been Withheld in Full as b4 (CCI/TS) immediately following this page

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PengDuan

Digitally signed by Peng DuanDate: 10/06/2017 03:46:02PMGUID: 54579633000330547a76e69866efb4b3

Tien MienChen

Digitally signed by Tien Mien ChenDate: 10/06/2017 03:50:17PMGUID: 508da7240002a26723d38018ce005126

Reference ID: 4188796Reference ID: 4188796

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ErikaPfeiler

Digitally signed by Erika PfeilerDate: 7/11/2017 11:41:03AMGUID: 502d1da500002b6a73a00c0e0dff6e1d

EricAdeeku

Digitally signed by Eric AdeekuDate: 7/11/2017 11:22:18AMGUID: 508da70b00028e3db199467cfbd47cb0

Reference ID: 4188796Reference ID: 4188796


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