Document ID: FDA-2011-N-0002-0103
Agency: fda
Document Type: Notice
Title: Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Posted Date: 2011-09-08T04:00Z

[Federal Register Volume 76, Number 174 (Thursday, September 8, 2011)]
[Notices]
[Pages 55689-55690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22863]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Endocrinologic and Metabolic Drugs Advisory 
Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 2, 2011, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
589-5200.
    Contact Person: Paul Tran, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 
2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, e-
mail: EMDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), and follow the 
prompts to the desired center or product area. Please call the 
Information Line for up-to-date information on this meeting. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On November 2, 2011, the committee will discuss 
supplemental new drug applications 21-687 and 21-445, VYTORIN 
(ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively, 
MSP (Merck/Schering-Plough) Singapore Company, LLC. Simvastatin lowers 
lipids (fats that circulate in the bloodstream, including cholesterol) 
by inhibiting 3-hydroxy-3-methyl-glutaryl-CoA reductase, which is an 
enzyme involved in producing lipids in the body, and ezetimibe lowers 
lipids by inhibiting the absorption of cholesterol from the intestine. 
The proposed indication (use) of ZETIA in combination with simvastatin 
or VYTORIN is to reduce major cardiovascular events in patients with 
chronic kidney disease based on the results of the Study of Heart and 
Renal Protection (SHARP). SHARP was a clinical trial that studied the 
effect of VYTORIN compared with placebo on the occurrence of major 
cardiovascular events in patients with chronic kidney disease who did 
not have a history of myocardial infarction or coronary 
revascularization (heart bypass surgery or opening heart vessels with a 
balloon or stents). The primary outcome of major cardiovascular events 
was defined as the first occurrence of either nonfatal myocardial 
infarction, cardiac death, stroke, or coronary or noncoronary 
revascularization (including nontraumatic amputation). The primary 
analysis demonstrated that assignment to VYTORIN significantly reduced 
the relative risk of a major cardiovascular event by 16% compared to 
placebo.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
October 19, 2011. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those individuals interested in 
making formal oral presentations should notify the contact person and 
submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation on or before October 11, 2011. Time allotted 
for each presentation may be limited. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated 
during the scheduled open public hearing session, FDA may conduct a 
lottery to determine the

[[Page 55690]]

speakers for the scheduled open public hearing session. The contact 
person will notify interested persons regarding their request to speak 
by October 12, 2011.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Paul Tran at least 7 
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22863 Filed 9-7-11; 8:45 am]
BILLING CODE 4160-01-P