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 ........................................................................... November 9–10. 

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. 

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withdrawn, thereby waiving its 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 § 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 

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) 


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