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The Food and Drug Administration (FDA) is announcing a meeting of its Antiviral Drugs Advisory Committee.

May 19, 2005

8:00 am to 5:00 pm

Hilton Washington DC/North
Salons A, B, and C
620 Perry Pkwy.
Gaithersburg, MD

If you need directions or hotel accommodations, please contact the hotel at

301-977-8900 

Agenda:
The committee will discuss new drug application (NDA) 21-814, proposed trade name APTIVUS (Tipranavir) 250 milligram capsules, Boehringer Ingelheim Pharmaceuticals, Inc., indicated for the treatment of patients with human immunodeficiency virus, HIV.

Background material and meeting information will become available on the FDA website no later than one business day before the meeting. (You will need to select the appropriate committee link.  Please not that the information is not posted at this time.)

Procedure:
Interested persons may present data, information, or views - orally or in writing - on issues pending before the committee.

Written submissions should be submitted to the contact person (below) by May 6, 2005.

Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. at the meeting. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person (below) before May 6, 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.

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. No registration is required.

If you require special accommodations due to a disability, please contact Angie Whitacre at 301-827-7001, at least 7 days in advance of the meeting.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

Contact Person:
Anuja Patel, 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: patela@....

Please call the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and enter code 3014512531 for up-to-date information on this meeting.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

An archive of past list serve announcements is available on the FDA web site at http://www.fda.gov/oashi/aids/listserve/archive.html