Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Call to Order and Opening Remarks Claudia Kawas, MD
Introduction of Committee
Conflict of Interest Statement Anuja M. Patel, M.P.H.
On September 25, the committee will discuss supplementary new drug application (SNDA 20-717 /S-008) Provigil (modafinil) Tablets, Cephalon, Inc., indicated for use to improve wakefulness in patients with excessive sleepiness associated with disorders of sleep and wakefulness.
Overview of Issues
Sponsor Presentations Cephalon Incorporated
· Review of Excessive Sleepiness
· Overview of Efficacy and Safety
Questions from Committee to FDA
Open Public Hearing
Continuation of Committee Discussion and Response to FDA Questions