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