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|CDER||September 8, 2005
September 9, 2005
|8:00 a.m. - 5:00
8:00 a.m. - 5:00 p.m.
Holiday Inn Washington
On September 8, 2005, the committee will discuss new drug application (NDA) 21-868, proposed trade name EXUBERA (insulin recombinant deoxyribonucleic acid (rDNA) origin powder for oral inhalation), 1 milligram (mg) and 3 mg powder for inhalation, Pfizer, Inc., for the treatment of adult patients with diabetes mellitus.
On September 9, 2005, the committee will discuss new drug application (NDA) 21-865, proposed trade name PARGLUVA (muraglitazar) Tablets, 2.5 mg and 5 mg, Bristol-Myers Squibb, for the treatment of type II diabetes mellitus.
Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).
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 August 31, 2005. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on both days. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before August 31, 2005, 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.
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Cathy Groupe, 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, e-mail: GroupeC@cder.fda.gov.
Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512536.