FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING

DRAFT AGENDA

May 14, 2003

Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, MD

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

8:00 a.m. Call to Order Roy M. Gulick, M.D., M.P.H.

Chair, AVAC

Introduction of Committee

Conflict of Interest Statement Tara P. Turner, Pharm.D.

Executive Secretary, AVAC

8:15 a.m. Opening Remarks Debra B. Birnkrant, M.D. Director

Division of Antiviral Drug Products

FDA

8:30 a.m. Overview of Genital Herpes FDA Guest Speaker

9:00 a.m. Sponsor Presentation GlaxoSmithKline

Introduction David M. Cocchetto, Ph.D.

U.S. Regulatory Affairs

Study Design, Methods, and Results Stuart M. Harding, M.D.

Clinical Development and

Medical Affairs

Concluding Remarks Clarence L. Young, M.D.

Clinical Development and

Medical Affairs

9:45 a.m. Questions from the Committee

10:00 a.m. Break

10:15 a.m. FDA Presentation Harry Haverkos, M.D.

Medical Officer

Division of Antiviral Drug Products

Fraser Smith, Ph.D.

Statistical Reviewer

Division of Biometrics III

11:00 a.m. Questions from the Committee

11:15 a.m. Open Public Hearing

12:15 p.m. Lunch

1:15 p.m. Charge to the Committee/Questions for Discussion Debra B. Birnkrant, M.D.

4:00 p.m. Adjourn