208612Orig1s000 - Food and Drug Administration

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

208612Orig1s000

NON-CLINICAL REVIEW(S)

NDA 208612

Leslie McKinney, PhD

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH

PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION

Application number: Supporting document/s:

Applicant's letter date: CDER stamp date:

Product:

Indication: Applicant:

Review Division:

Reviewer: Supervisor/Team Leader:

Division Director: Project Manager:

20816 SDN25 January 9, 2018 January 9, 2018 Ethinyl Estradiol / Levonorgestrel and Ferrous Bisglycinate Prevention of pregnancy Neuvosyn Laboratories LLC Division of Bone, Reproductive, and Urologic Drug Products (DBRUP) Leslie McKinney, PhD Mukesh Summan, PhD, DABT Hylton Joffe, MD, MMSc Jennifer Dao

Memo to file for labeling:

I have reviewed the label for this product and concur with final wording. The label has been updated for PLLR and follows standard labeling for oral contraceptives. There are no nonclinical data in the label.

Reference ID: 4205191

--------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. ---------------------------------------------------------------------------------------------------------

/s/ ---------------------------------------------------LESLIE C MCKINNEY 01/09/2018 MUKESH SUMMAN 01/09/2018

Reference ID: 4205191

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH

PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION

Application number: Supporting document/s: Applicant's letter date: CDER stamp date:

Product:

Indication: Applicant:

Review Division:

Reviewer: Supervisor/Team Leader: Division Director: Project Manager:

208612 SDN2 March 16, 2017 March 16, 2017 Ethinyl Estradiol / Levonorgestrel and Ferrous Bisglycinate Prevention of pregnancy Neuvosyn Laboratories LLC Division of Bone, Reproductive and Urologic Products (DBRUP) Leslie McKinney, PhD Mukesh Summan, PhD, DABT Hylton Joffe, MD, MMSc Jennifer Dao

Disclaimer

This is a 505b2 application. Except as specifically identified, all data and information discussed below and necessary for approval of NDA 208612 are owned by Neuvosyn Laboratories or are data for which Neuvosyn has obtained a written right of reference. Any information or data necessary for approval of NDA20812 that Neuvosyn does not own or have a written right to reference constitutes one of the following: (1) published literature, or (2) a prior FDA finding of safety or effectiveness for a listed drug, as reflected in the drug's approved labeling. Any data or information described or referenced below from reviews or publicly available summaries of a previously approved application is for descriptive purposes only and is not relied upon for approval of NDA 208612.

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Reference ID: 4192838

NDA #208612

Reviewer: Leslie McKinney, PhD

TABLE OF CONTENTS

1 EXECUTIVE SUMMARY ......................................................................................... 3

1.1 INTRODUCTION .................................................................................................... 3 1.2 BRIEF DISCUSSION OF NONCLINICAL FINDINGS ...................................................... 3 1.3 RECOMMENDATIONS ............................................................................................ 3

2 DRUG INFORMATION ............................................................................................ 6

2.1 DRUG ................................................................................................................. 6 2.2 RELEVANT INDS, NDAS, BLAS AND DMFS........................................................... 6 2.3 DRUG FORMULATION ........................................................................................... 7 2.4 COMMENTS ON NOVEL EXCIPIENTS....................................................................... 7 2.5 COMMENTS ON IMPURITIES/DEGRADANTS OF CONCERN ......................................... 8 2.6 PROPOSED CLINICAL POPULATION AND DOSING REGIMEN ...................................... 8 2.7 REGULATORY BACKGROUND ................................................................................ 8

3 STUDIES SUBMITTED............................................................................................ 9

3.1 STUDIES REVIEWED............................................................................................. 9 3.2 STUDIES NOT REVIEWED ..................................................................................... 9 3.3 PREVIOUS REVIEWS REFERENCED........................................................................ 9

6 GENERAL TOXICOLOGY..................................................................................... 10

6.1 SINGLE-DOSE TOXICITY ..................................................................................... 10 6.2 REPEAT-DOSE TOXICITY .................................................................................... 10

9 REPRODUCTIVE AND DEVELOPMENTAL TOXICOLOGY ................................ 11

11 INTEGRATED SUMMARY AND SAFETY EVALUATION................................. 12

12 APPENDIX/ATTACHMENTS ............................................................................. 12

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Reference ID: 4192838

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