[Federal Register Volume 68, Number 7 (Friday, January 10, 2003)]
[Notices]
[Page 1469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-493]



[[Page 1469]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0529]


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

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 REZULIN (troglitazone) Tablets held 
by Pfizer, Inc., 235 East 42d Street, New York, NY 10017. Pfizer has 
voluntarily withdrawn this NDA because the product is no longer 
marketed, thereby waiving its opportunity for a hearing.

DATES: Effective January 10, 2003.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In a letter dated May 1, 2002, Pfizer, Inc., 
requested that FDA withdraw under Sec.  314.150(d) (21 CFR 314.150(d)), 
NDA 20-720 for REZULIN (troglitazone) Tablets, stating that The Warner-
Lambert Co., which Pfizer acquired in June 2000, discontinued marketing 
the product in March 2000. REZULIN (troglitazone) Tablets, a treatment 
for type 2 diabetes, was voluntarily withdrawn after review of safety 
data showed that the drug is more toxic to the liver than two other 
more recently approved drugs that offer a similar benefit. Pfizer 
waived its opportunity for a hearing, provided under Sec.  314.150(a) 
and (b).
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 355(e)) and under authority delegated 
to the Director, Center for Drug Evaluation and Research (21 CFR 
5.105(a)), approval of the NDA 20-720, and all amendments and 
supplements thereto, is withdrawn. 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 act 
(21 U.S.C. 355(a) and 331(d)).

    Dated: December 16, 2002.
Jane Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 03-493 Filed 1-9-03; 8:45 am]
BILLING CODE 4160-01-S