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Cardiovascular and Renal Drugs Advisory Committee

Agenda:
On June 15, 2005, the committee will discuss class labeling of antihypertensive drugs based on the proximity of their data to outcome trials.

On June 16, 2005, the committee will discuss new drug application (NDA) 20-727, proposed trade name BIDIL (hydralazine hydrochloride/isosorbide dinitrate) Tablets, (37.5 milligrams (mg) hydralazine hydrochloride/20 mg isosorbide dinitrate), NitroMed, Inc., proposed for the indication of heart failure, based on the results from the African American Heart Failure Trial.

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).

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 June 8, 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 June 8, 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.

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 Beverly O’Neil at 301-827-7001 at least 7 days in advance of the meeting.

Contact Person:
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 3014512533.