Abbott Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for MERIDIA, 80061 [2010-31986]

Download as PDF Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Notices 80061 TABLE 1—Continued Committee name Tentative date(s) of meeting(s) CENTER FOR FOOD SAFETY AND APPLIED NUTRITION Food Advisory Committee ........................................................................ March 30–31. CENTER FOR TOBACCO PRODUCTS Tobacco Products Scientific Advisory Committee ................................... January 10–11, March 17–18, May, July, September, and November date(s), if needed, to be determined. CENTER FOR VETERINARY MEDICINE Veterinary Medicine Advisory Committee ................................................ April 11, September 12. NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH Science Advisory Board ........................................................................... Dated: December 16, 2010. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2010–31961 Filed 12–20–10; 8:45 am] BILLING CODE 4160–01–P 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. 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 Abbott has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.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 srobinson on DSKHWCL6B1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 20:40 Dec 20, 2010 Jkt 223001 November 9–10. 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 § 314.150(d) (21 CFR 314.150(d)). In that letter, Abbott also waived its opportunity for a hearing, provided under § 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)), § 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Unsolicited Multi-Project (P01) Grant Applications. Date: January 12, 2011. Time: 1 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6700B Rockledge Drive, Bethesda, MD 20817. (Telephone Conference Call.) Contact Person: Roberta Binder, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, NIAID/NIH/DHHS, 6700B Rockledge Drive, Room 3130, Bethesda, MD 20892–7616. 301– 496–7966. rbinder@niaid.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) E:\FR\FM\21DEN1.SGM 21DEN1

Agencies

[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.

-----------------------------------------------------------------------

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

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