[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46984-46985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0869]


Pfizer, Inc.; Withdrawal of Approval of a New Drug Application 
for BEXTRA

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 BEXTRA (valdecoxib) 10 milligram 
(mg) and 20 mg Tablets, held by Pfizer, Inc. (Pfizer), 235 East 42nd 
St., New York, NY 10017-5755. Pfizer has voluntarily requested that 
approval of this application be withdrawn and has waived its 
opportunity for a hearing.

DATES: Effective August 2, 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: FDA approved BEXTRA (valdecoxib) 10 mg and 
20 mg Tablets on November 16, 2001. BEXTRA is indicated for relief of 
the signs and symptoms of osteoarthritis and adult rheumatoid arthritis 
and for the treatment of primary dysmenorrhea. On April 7, 2005, FDA 
announced that it had concluded that the overall risk versus benefit 
profile of BEXTRA was unfavorable and that it had asked Pfizer to 
voluntarily withdraw BEXTRA from the market. Pfizer agreed and 
voluntarily suspended all sales and marketing of BEXTRA on July 21, 
2005. In letters dated May 27, 2011, August 8,

[[Page 46985]]

2011, and October 31, 2011, Pfizer requested that FDA withdraw approval 
of NDA 21-341 for BEXTRA. In the letter dated October 31, 2011, Pfizer 
waived any opportunity for a hearing otherwise provided under 21 CFR 
314.150 (Sec.  314.150). In FDA's letter of November 9, 2011, 
responding to Pfizer's letters dated May 27, 2011, August 8, 2011, and 
October 31, 2011, the Agency acknowledged Pfizer's request to withdraw 
approval of BEXTRA 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 (the FD&C Act) (21 U.S.C. 355(e)) and Sec.  314.150(d), 
and under authority delegated by the Commissioner to the Director, 
Center for Drug Evaluation and Research, approval of NDA 21-341, 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: July 30, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-18657 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P