• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Advisory Committees

  • Print
  • Share
  • E-mail

December 15, 2009: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

CDERDecember 15, 2009
8:00 a.m. – 5:00 p.m.
Hilton Washington DC North/Gaithersburg
The Ballrooms
620 Perry Parkway
Gaithersburg, Maryland


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 a 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.”

Meeting Materials

Public Participation Information

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., December 15. 2009. 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.

Contact Information

  • Paul Tran, R.Ph.
    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
    Phone: 301-827-7001
    Fax: 301-827-6776
    E-mail: paul.tran@fda.hhs.gov
  • FDA Advisory Committee Information Line
    (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 notice. Therefore, you should always check the agency’s Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

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.

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 (301) 827-7001 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 Public Conduct During FDA Advisory Committee Meetings 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).