[Federal Register Volume 77, Number 111 (Friday, June 8, 2012)]
[Notices]
[Page 34052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-13900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0494]


Pfizer, Inc.; Withdrawal of Approval of Familial Adenomatous 
Polyposis Indication for CELEBREX

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of the familial adenomatous polyposis (FAP) indication for CELEBREX 
(celecoxib) Capsules held by Pfizer, Inc. (Pfizer), 235 East 42nd St., 
New York, NY 10017-5755. Pfizer has voluntarily requested that approval 
of this indication be withdrawn, thereby waiving its opportunity for a 
hearing.

DATES: Effective June 8, 2012.

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 the FAP indication for CELEBREX 
on December 23, 1999, under the Agency's accelerated approval 
regulations, 21 CFR part 314, subpart H. In addition to FAP, CELEBREX 
is indicated for the relief of the signs and symptoms of 
osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in 
patients 2 years and older, ankylosing spondylitis, primary 
dysmenorrhea, and for the management of acute pain in adults. 
Withdrawal of approval of the FAP indication does not affect any other 
approved indication for CELEBREX. On February 2, 2011, FDA requested 
that Pfizer voluntarily withdraw the FAP indication for CELEBREX 
(celecoxib) Capsules from the market because the postmarketing study 
intended to verify clinical benefit and required as a condition of 
approval under subpart H was never completed. In a letter dated 
February 3, 2011, Pfizer requested that FDA withdraw the FAP indication 
for CELEBREX (celecoxib) Capsules from the market. In that letter, 
Pfizer waived any opportunity for a hearing otherwise provided under 21 
CFR 314.150 and 314.530, and noted that withdrawal of the FAP 
indication was not ``due to any new efficacy or safety data.'' In FDA's 
letter of February 4, 2011, the Agency acknowledged Pfizer's agreement 
to permit FDA to withdraw the FAP indication for CELEBREX (celecoxib) 
Capsules under 21 CFR 314.150(d) and waive its opportunity for a 
hearing.
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)) and 21 CFR 314.150(d), and under 
authority delegated by the Commissioner to the Director, Center for 
Drug Evaluation and Research, approval of the FAP indication for 
CELEBREX (celecoxib) Capsules is withdrawn (see DATES).

    Dated: May 4, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2012-13900 Filed 6-7-12; 8:45 am]
BILLING CODE 4160-01-P