FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING
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. Public Health Aspects of Genital Herpes H. Hunter Handsfield, M.D.
Professor of Medicine
University of Washington
Director, STD Control Program
Public Health – Seattle & King County
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