Food and Drug Administration

Center for Drug Evaluation and Research (CDER)


Peripheral and Central Nervous System Drugs Advisory Committee


September 25, 2003


Holiday Inn

8120 Wisconsin Avenue, Bethesda, Maryland





8:00 Call to Order and Opening Remarks Claudia Kawas, MD


Introduction of Committee


Conflict of Interest Statement Anuja M. Patel, M.P.H.

Executive Secretary, FDA


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.


8:15 Opening Remarks FDA

Overview of Issues


8:45 Sponsor Presentations Cephalon Incorporated



       Review of Excessive Sleepiness

       Overview of Efficacy and Safety

9:45 FDA Presentation


11:15 Questions from Committee to FDA


12:00 Lunch


1:00 Open Public Hearing


2:00 Continuation of Committee Discussion and Response to FDA Questions




5:00 Adjourn