Document ID: FDA-2013-N-0559-0001
Agency: fda
Document Type: Notice
Title: Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX
Posted Date: 2013-06-04T04:00Z

[Federal Register Volume 78, Number 107 (Tuesday, June 4, 2013)]
[Notices]
[Pages 33426-33427]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13053]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0559]

Eli Lilly and Co.; Withdrawal of Approval of a New Drug 
Application for ORAFLEX

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 ORAFLEX (benoxaprofen) Tablets, 
held by Eli Lilly and Co. (Lilly), Lilly Corporate Center, 
Indianapolis, IN 46285. Lilly has voluntarily requested that approval 
of this application be withdrawn, and has waived its opportunity for a 
hearing.

DATES: Effective June 4, 2013.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6250, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: On April 19, 1982, FDA approved ORAFLEX 
(benoxaprofen) Tablets, a nonsteroidal

[[Page 33427]]

anti-inflammatory drug indicated for the treatment of arthritis. On 
August 4, 1982, Lilly voluntarily withdrew ORAFLEX (benoxaprofen) 
Tablets from the market because of postmarketing reports of severe 
liver toxicity in patients who took ORAFLEX. In a letter dated February 
6, 2013, Lilly requested that FDA withdraw approval of NDA 18-250 for 
ORAFLEX (benoxaprofen) Tablets under Sec.  314.150(d) (21 CFR 
314.150(d)). In that letter, Lilly waived any opportunity for a hearing 
otherwise provided under Sec.  314.150(a). In FDA's letter of February 
15, 2013, the Agency acknowledged Lilly's agreement to permit FDA to 
withdraw approval of ORAFLEX (benoxaprofen) Tablets under Sec.  
314.150(d) and waive its opportunity for a hearing.
    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 18-
250, 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: May 28, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-13053 Filed 6-3-13; 8:45 am]
BILLING CODE 4160-01-P