Antiviral Drugs Advisory Committee Meeting - Atazanavir / valacyclovir
The Food and Drug Administration (FDA) will hold a meeting of its Antiviral Drugs Advisory Committee on on May 13 and 14, 2003, from 8 a.m. to 5 p.m. at the Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, MD.
On May 13, 2003, the committee will discuss new drug applications (NDA) 21-567 and 21-568, Reyataz™ (atazanavir sulfate) capsules and powder for oral use, Bristol-Myers Squibb Company, proposed for the treatment of HIV infection in combination with other antiretroviral agents.
On May 14, 2003, the committee will discuss supplemental new drug application (sNDA) 20-550/S-019, Valtrex® (valacyclovir hydrochloride) caplets, GlaxoSmithKline, proposed for reduction of the risk of transmission of genital herpes with the use of suppressive therapy.
The meeting will be open to the public. No registration is necessary. If you need directions or accommodations, please contact the hotel directly at 301.948-8900
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to Tara P. Turner, Pharm.D (see contact information below) by May 6, 2003. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on May 13, 2003, and between approximately 11 a.m. and 12 noon on May 14, 2003. Time allotted for each presentation may be limited depending on number of speakers. Those desiring to make formal oral presentations should notify the contact person before May 6, 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 Tara Turner at least 7 days in advance of the meeting.
Contact Person: Tara P. Turner, Pharm.D., 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: TurnerT@cder.fda.gov
Please call the FDA Advisory Committee Information Line for up-to-date information about this meeting.
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and enter code 12531.
Office of Special Health Issues
Food and Drug Administration