[Federal Register Volume 68, Number 154 (Monday, August 11, 2003)]
[Notices]
[Page 47581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-20383]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0350]


Sankyo Pharma, 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 PRELAY (troglitazone) Tablets held 
by Sankyo Pharma, Inc. (Sankyo Pharma), 399 Thornall St., Edison, NJ 
08837. Sankyo Pharma has requested that approval of this application be 
withdrawn because the product is not being marketed, thereby waiving 
its opportunity for a hearing.

DATES: Effective August 11, 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 December 31, 2002, Sankyo 
Pharma requested that FDA withdraw approval, under Sec.  314.150(d) (21 
CFR 314.150(d)), of NDA 20-719 for PRELAY (troglitazone) Tablets. 
Sankyo U.S.A. Corp. (Sankyo U.S.A.) filed NDA 20-719 for PRELAY 
concurrently with Warner-Lambert Co.'s NDA 20-720 for REZULIN. Both 
these applications were for troglitazone tablets. Sankyo U.S.A. merged 
into Sankyo Pharma in December 1999. Neither Sankyo U.S.A. nor Sankyo 
Pharma has ever marketed PRELAY, and Sankyo Pharma has no plans to 
market troglitazone in the future. FDA has determined that never 
marketing an approved drug product is equivalent to withdrawing the 
drug from sale. PRELAY, a treatment for type 2 diabetes, was 
voluntarily withdrawn after review of safety data showed that REZULIN 
is more toxic to the liver than two other more recently approved drugs 
that offer a similar benefit (see the REZULIN withdrawal notice that 
published in the Federal Register of January 10, 2003 (68 FR 1469)). 
Sankyo Pharma 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 20-719, and all amendments and 
supplements thereto, is withdrawn, effective August 11, 2003. 
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: July 10, 2003.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 03-20383 Filed 8-8-03; 8:45 am]
BILLING CODE 4160-01-S