Notice of FDA Advisory Committee Meeting on February 27, 2001

The FDA Antiviral Drugs Advisory Committee will meet on February 27, 2001, to discuss data related to the safety and effectiveness of valganciclovir hydrochloride 450 mg tablets, proposed for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. The drug sponsor is Syntex (USA).

This meeting is scheduled to take place from 9:00 a.m. to 5:30 p.m. at the Holiday Inn (the Ballrooms), 2 Montgomery Avenue, Gaithersburg, MD. You can contact the hotel directly at 301.948.8900 for directions or accommodation information.

The public is invited and encouraged to attend FDA advisory committee meetings. No registration is required.

Interested persons may present data, information, or views -- orally or in writing -- related to the consideration of valganciclovir for the treatment of CMV retinitis in patients with AIDS.

If you would like to make an oral presentation on February 27, please send the following information to Tara Turner, Pharm. D., Center for Drug Evaluation and Research (HFD-21), 5600 Fishers Lane, Rockville, MD 20857, 301.827.7001, e-mail TurnerT@cder.fda.gov, or by fax to 301.827.6776, by February 20, 2001.

• Name of speaker (and organization/affiliation if appropriate)

• Address, phone and fax numbers

• A brief summary statement of your comments

• Approximate amount of time you would like to speak

Oral presentations from the public are scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited, depending on the number of speakers.

Written information may be submitted to Dr. Turner at the same mailing or e-mail address, or by fax. Written information should also be received before February 20, 2001.

For up-to-date information about this meeting, please call the FDA Advisor Committee Information Line, 1.800.741.8138 (301.443.0572 in the Washington D.C. area) and press code 12531.

For general information, contact Richard Klein, Office of Special Health Issues, 301.827.4460, or e-mail Rklein@oc.fda.gov.