Food and Drug Administration
Center for Drug Evaluation and Research
Arthritis Advisory Committee
Silver Spring Holiday Inn,
NDA: 20-905, ARAVAÔ, (leflunomide), Aventis Pharmaceuticals Inc.
Call to Order and Introductions: Steven B. Abramson,, M.D., Acting Chair
Open Public Hearing
Regulatory History: Arava and Treatment of Rheumatoid Arthritis:
Lee S. Simon, M.D.
Health Assessment Questionnaire: James F. Fries, M.D.,
Aventis Presentation: Efficacy: Michael Rozycki, Ph.D.
Joseph Doyle, R.PH., MBA.
Karen Simpson, M.D.
Statistics: Suktae Choi, Ph.D., FDA
Discussion and Questions: Efficacy
Open Public Hearing (if needed)
FDA Presentation: Safety:
Aventis Presentation: Safety: Michael Rozycki, Ph.D.
William Holden, M.D.
Vibeke Strand, M.D.
Discussion of labeling rare serious
events: Ruth Day, Ph.D.,
Discussion and Questions: Safety