
[Federal Register Volume 75, Number 244 (Tuesday, December 21, 2010)]
[Notices]
[Page 80061]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31986]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0626]


Abbott Laboratories, Inc.; Withdrawal of Approval of a New Drug 
Application for MERIDIA

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 MERIDIA (sibutramine hydrochloride 
(HCl)) oral capsules held by Abbott Laboratories, Inc. (Abbott), 100 
Abbott Park Rd., Abbott Park, IL 60064. Abbott has voluntarily 
requested that approval of this application be withdrawn, thereby 
waiving its opportunity for a hearing.

DATES: Effective December 21, 2010.

FOR FURTHER INFORMATION CONTACT: Nicole Mueller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6312, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: On October 7, 2010, FDA requested that 
Abbott voluntarily withdraw MERIDIA (sibutramine HCl) oral capsules 
from the market, based on FDA's recent analysis of clinical trial data 
from the Sibutramine Cardiovascular Outcomes Trial (SCOUT) that 
indicated that MERIDIA poses an increased risk of heart attack and 
stroke. In a letter dated October 12, 2010, Abbott requested that FDA 
withdraw approval of NDA 20-632 for MERIDIA (sibutramine HCl) oral 
capsules under Sec.  314.150(d) (21 CFR 314.150(d)). In that letter, 
Abbott also waived its opportunity for a hearing, provided under Sec.  
314.150(a). In FDA's acknowledgment letter of November 1, 2010, the 
agency stated that based on the review of the SCOUT data and the 
assessment of the September 15, 2010, meeting of FDA's Endocrinologic 
and Metabolic Drugs Advisory Committee at which the SCOUT data were 
reviewed, we find the benefits of MERIDIA (sibutramine HCl) oral 
capsules, indicated for the management of obesity, including weight 
loss and maintenance of weight loss, no longer outweigh the risks in 
any identifiable patient population. FDA also acknowledged that Abbott 
waived its opportunity for a hearing.
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)), Sec.  314.150(d), and under 
authority delegated by the Commissioner of Food and Drugs to the 
Director, Center for Drug Evaluation and Research, approval of NDA 20-
632, 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: December 6, 2010.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2010-31986 Filed 12-20-10; 8:45 am]
BILLING CODE 4160-01-P


