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

 

 

Draft AGENDA

 

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

Chair

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

       Introduction

 

       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

 

Break

 

5:00 Adjourn