Document ID: FDA-2012-N-0690-0001
Agency: fda
Document Type: Notice
Title: Withdrawals of Approvals of New Drug Applications: DURACT Capsules; Wyeth Pharmaceuticals, Inc.
Posted Date: 2012-07-09T04:00Z

[Federal Register Volume 77, Number 131 (Monday, July 9, 2012)]
[Notices]
[Page 40367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16597]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0690]

Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug 
Application for DURACT Capsules

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new drug application (NDA) for DURACT (bromfenac sodium) Capsules, 
held by Wyeth Pharmaceuticals, Inc. (Wyeth), P.O. Box 8299, 
Philadelphia, PA 19101-8299. Wyeth, now a part of Pfizer, Inc., has 
voluntarily requested that approval of this application be withdrawn, 
thereby waiving its opportunity for a hearing.

DATES: Effective July 9, 2012.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In June 1998, Wyeth voluntarily withdrew 
DURACT (bromfenac sodium) Capsules from the market. DURACT (bromfenac 
sodium) Capsules, a nonsteroidal anti-inflammatory drug indicated for 
the short-term management of acute and chronic pain, were withdrawn 
from the market after FDA and Wyeth received postmarketing reports of 
rare, severe liver toxicity in patients who took DURACT for periods of 
time beyond that recommended in the labeling.
    In a letter dated December 9, 2011, Wyeth requested that FDA 
withdraw approval of NDA 20-535, DURACT (bromfenac sodium) Capsules, 
under Sec.  314.150(d) (21 CFR 314.150(d)). In that letter, Wyeth also 
waived its opportunity for a hearing, provided under Sec.  314.150(a).
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and Sec.  314.150(d), and 
under authority delegated by the Commissioner of Food and Drugs to the 
Director, Center for Drug Evaluation and Research, approval of NDA 20-
535, and all amendments and supplements thereto, is withdrawn (see 
DATES). Distribution of this product in interstate commerce without an 
approved application is illegal and subject to regulatory action (see 
sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 
331(d)).

    Dated: June 21, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2012-16597 Filed 7-6-12; 8:45 am]
BILLING CODE 4160-01-P