Document ID: FDA-2009-N-0664-0107
Agency: fda
Document Type: Notice
Title: Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Posted Date: 2009-10-27T04:00Z

[Federal Register: October 27, 2009 (Volume 74, Number 206)]
[Notices]               
[Page 55243-55244]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc09-66]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
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 December 15, 2009, 
from 8 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The 
Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. The hotel telephone 
number is 301-977-8900.
    Contact Person: Paul Tran, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane 
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 
20857, 301-827-7001, FAX: 301-827-6776, e-mail: 
paul.tran@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 
3014512536. 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

[[Page 55244]]

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 December 15, 2009, the committee will discuss 
supplemental new drug application (sNDA) 21-366, CRESTOR 
(rosuvastatin calcium) tablets, AstraZeneca Pharmaceuticals. CRESTOR 
is a member of the statin drug class which lowers lipids (fats that 
circulate in the bloodstream, including cholesterol) by inhibiting 
HMG-CoA reductase, an enzyme involved in producing lipids in the 
body. The proposed indication (use) of CRESTOR in this application 
is primary prevention of cardiovascular disease based on the results 
of JUPITER. JUPITER was a clinical trial that studied individuals 
who did not have obvious or overt cardiovascular disease, but did 
have the following characteristics: Low or normal levels of the 
variety of cholesterol known as low-density lipoprotein, or LDL; 
elevated levels of C-reactive protein (hsCRP), a marker of 
inflammation in the body, and at least one of the conventional risk 
factors for cardiovascular disease. (The ``conventional risk 
factors'' are smoking, age, high blood pressure, low levels of the 
good cholesterol, HDL, and family history of heart disease). In 
these individuals, JUPITER evaluated the reduction of risk with 
rosuvastatin therapy on the study's combined objectives (known as 
the study's ``composite endpoint'') which included: Death from heart 
disease (heart attack) or vascular disease (stroke), heart attack 
that did not result in death, stroke that did not result in death, 
unstable angina (when the heart does not get enough blood flow, 
often a warning of heart attack), and heart or blood vessel disease 
that necessitates arterial revascularization, commonly known as 
``bypass surgery.''
    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 
December 1, 2009. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. Those desiring to 
make 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 November 20, 2009. 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 speakers for the scheduled 
open public hearing session. The contact person will notify 
interested persons regarding their request to speak by November 23, 
2009.
    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: October 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25805 Filed 10-26-09; 8:45 am]

BILLING CODE 4160-01-S