[Federal Register Volume 72, Number 19 (Tuesday, January 30, 2007)]
[Notices]
[Page 4270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1414]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0029]


Indevus Pharmaceuticals, 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 REDUX (dexfenfluramine 
hydrochloride (HCl)) Capsules held by Indevus Pharmaceuticals, Inc. 
(Indevus), 33 Hayden Ave., Lexington, MA 02421-7971. Indevus has 
requested that approval of this application be withdrawn because the 
product is no longer marketed, thereby waiving its opportunity for a 
hearing.

DATES: Effective January 30, 2007.

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 1997, FDA asked that REDUX 
(dexfenfluramine HCl) be withdrawn from the market because of safety 
concerns; Indevus (formerly Interneuron Pharmaceuticals, Inc.) 
discontinued marketing this product. REDUX (dexfenfluramine 
HCl)Capsules, a treatment for obesity, was withdrawn from the market 
after review of safety data showed that the product is associated with 
valvular heart disease (see FDA press releases on ``Health Advisory on 
Fenfluramine/Phentermine for Obesity,'' dated July 8, 1997, (http://www.fda.gov/opacom/hpnews.html), and ``FDA Announces Withdrawal of 
Fenfluramine and Dexfenfluramine,'' dated September 15, 1997, (http://www.fda.gov/opacom/hpnews.html)).
    In a letter dated January 16, 2006, Indevus requested that FDA 
withdraw approval, under Sec.  314.150(d) (21 CFR 314.150(d)), of NDA 
20-344 for REDUX (dexfenfluramine HCl) Capsules, stating that it had 
discontinued marketing the product. The letter also stated that Indevus 
believes that the risk/benefit ratio for the use of dexfenfluramine is 
unfavorable and that withdrawal of approval of NDA 20-344 is in the 
best interest of public health. Indevus voluntarily waived its 
opportunity for a hearing, provided under Sec.  314.150(a) and (b).
    Therefore, under section 505(e) of Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 355(e)), Sec.  314.150(d), and under authority 
delegated to the Director, Center for Drug Evaluation and Research, by 
the Commissioner of Food and Drugs, approval of NDA 20-544, and all 
amendments and supplements thereto, is withdrawn, effective January 30, 
2007. 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. 331(d)).

    Dated: January 12, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E7-1414 Filed 1-29-07; 8:45 am]
BILLING CODE 4160-01-S