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| Center | Date | Time | Location |
|---|---|---|---|
| CDER | July 9, 2003 | 8:30 a.m. - 5:00 p.m. | Holiday Inn |
Agenda:
The committee will discuss new drug application (NDA) 21-366, CRESTOR (rosuvastatin
calcium) tablets, AstraZeneca Pharmaceuticals LP, agent for iPR Pharmaceuticals,
Inc., for the proposed indication of treatment of hypercholesterolemia and mixed
dyslipidemia.
Background material will become available no later than the day before the meeting and will be posted under the Dockets Management Branch site at http://www.fda.gov/ohrms/dockets/ac/03acdocs.htm. (Scroll down and select 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 by July 1, 2003. Oral presentations from the public will be scheduled
between approximately 1:30 p.m. and 2:30 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before July 1, 2003, 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. 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 Dornette Spell-LeSane at least 7 days in advance of the meeting.
Contact Person:
Dornette Spell-LeSane, NP-C, 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 spelllesaned@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12536. Please call the Information Line for up-to-date
information on this meeting.