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CENTER FOR DRUG EVALUATION AND RESEARCH

Approval Package for:

APPLICATION NUMBER:

NDA 202379/S006

Trade Name:

Zytiga

Generic Name:

abiraterone acetate

Sponsor:

Janssen Biotech, Inc.

Approval Date:

June 17, 2013

Indication: ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration resistant prostate cancer.


APPLICATION NUMBER:

NDA 202379/S006

CONTENTS

Reviews / Information Included in this NDA Review. Approval Letter X Other Action Letters Labeling REMS Summary Review Officer/Employee List Office Director Memo Cross Discipline Team Leader Review Medical Review(s) Chemistry Review(s) X Environmental Assessment Pharmacology Review(s) Statistical Review(s) Microbiology Review(s) Clinical Pharmacology/Biopharmaceutics Review(s) Other Reviews Risk Assessment and Risk Mitigation Review(s) Proprietary Name Review(s) Administrative/Correspondence Document(s) X


APPLICATION NUMBER:

NDA 202379/S006

APPROVAL LETTER

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration Silver Spring MD 20993

NDA 202-379/S-006

APPROVAL LETTER Janssen Biotech, Inc. c/o Janssen Research & Development, LLC Attention: Jennifer Wilkinson Associate Director Regulatory Affairs 1125 Trenton Harbourton Road Titusville, NJ 08560 Dear Ms. Wilkinson: Please refer to your Supplemental New Drug Application (sNDA) dated December 17, 2012, received December 17, 2012, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Zytiga© (abiraterone acetate) Tablets. We acknowledge receipt of your amendment dated May 21, 2013. This “Changes Being Effected in 30 days” supplemental new drug application provides for a change in the We have completed our review of this supplemental new drug application, as amended. This supplement is approved. We remind you that you must comply with the requirements for an approved NDA set forth under 21 CFR 314.80 and 314.81. If you have any questions, call Yvonne Knight, Regulatory Project Manager, at (301) 796-2133.

Sincerely, {See appended electronic signature page}

Hasmukh B. Patel, Ph.D. Branch Chief Branch III, Division of New Quality Assessment I Office of New Drug Quality Assessment Center for Drug Evaluation and Research

Reference ID: 3326397

(b) (4)

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

NALLAPERUM CHIDAMBARAM06/17/2013for Dr. Hasmukh Patel



APPLICATION NUMBER:

NDA 202379/S006

CHEMISTRY REVIEW(S)

NDA 20-2379 / S-006 ZYTIGA (abiraterone acetate) Tablets JANSSEN BIOTECH, INC.

Page 2 of 5

CONCLUSIONS & RECOMMENDATIONS: The CMC information presented in the submission to support the requested change is acceptable. The supplement is recommended for APPROVAL. cc: Orig. NDA 20-2379 DMIHP/Division File DMIHP/CSO/Y.Knight . filename: n202379s.006.doc Allan Fenselau, Ph.D., Review Chemist

DRAFT SUPPLEMENT LETTER

There are no CMC–specific deficiencies.


(b) (4)

3 Pages Immediately Following Withheld - b(4)


ALLAN H FENSELAU05/28/2013

HASMUKH B PATEL05/28/2013



APPLICATION NUMBER:

NDA 202379/S006

ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS


YVONNE L KNIGHT05/31/2013


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration Silver Spring MD 20993

NDA 202379/S-006

CBE SUPPLEMENT – ACKNOWLEDGEMENT

Janssen Research & Development, L.L.C. On behalf of Janssen Biotech, Inc. Attention: Steven Rabin, Ph.D. Manager, Global CMC Regulatory Affairs 6500 Paseo Padre Parkway Fremont, CA 94555 Dear Dr. Rabin: We have received your Supplemental New Drug Application (sNDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA or the Act) for the following: NDA NUMBER: 202379 SUPPLEMENT NUMBER: S-006 PRODUCT NAME: Zytiga® (abiraterone acetate) Tablets DATE OF SUBMISSION: December 17, 2012 DATE OF RECEIPT: December 17, 2012 This supplemental application, submitted as a “Changes Being Effected in 30 days” supplement, provides for a change to the The application has been filed in accordance with 21 CFR 314.101(a). The user fee goal date is June 17, 2013. Cite the application number listed above at the top of the first page of all submissions to this application. Send all submissions, electronic or paper, including those sent by overnight mail or courier, to the following address:


(b) (4)

202379/S-006 Page 2

Food and Drug Administration Center for Drug Evaluation and Research Division of Oncology Products I 5901-B Ammendale Road Beltsville, MD 20705-1266

All regulatory documents submitted in paper should be three-hole punched on the left side of the page and bound. The left margin should be at least three-fourths of an inch to assure text is not obscured in the fastened area. Standard paper size (8-1/2 by 11 inches) should be used; however, it may occasionally be necessary to use individual pages larger than standard paper size. Non-standard, large pages should be folded and mounted to allow the page to be opened for review without disassembling the jacket and refolded without damage when the volume is shelved. Shipping unbound documents may result in the loss of portions of the submission or an unnecessary delay in processing which could have an adverse impact on the review of the submission. For additional information, see http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/ucm073080.htm.

If you have any questions, call Deborah Mesmer, Regulatory Project Manager, at (301) 796-4023.

Sincerely, {See appended electronic signature page} Deborah M. Mesmer, M.S. Regulatory Health Project Manager for Quality Division of New Drug Quality Assessment I Office of New Drug Quality Assessment Center for Drug Evaluation and Research



DEBORAH M MESMER03/26/2013


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