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Food and Drug Administration

Psychopharmacologic Drugs Advisory Committee

March 23, 2006


New Drug Application (NDA) 20-717/ S -019, trade name Provigil® Tablets, Cephalon, Inc., proposed indication is for treatment of attention-deficit/ hyperactivity disorder (ADHD).


Slides Presented at the Meeting



FDA Presentations


Clinical Review


Glenn Mannheim, M.D.

Medical Officer, Division of Psychiatry Products CDER, FDA

Modafinil for the Treatment of ADHD  


Paul J. Andreason, M.D.

Deputy Director, Division of Psychiatry Products


Serious Adverse Cutaneous Reactions to Drugs 

(PPT) (HTM)  


Michael E. Bigby, M.D.

Associate Professor

Beth Israel Deaconess Medical Center

Cephalon Presentation






Victor Raczkowski, M.D.

Vice President, Worldwide Regulatory Affairs

Cephalon, Inc.


Overview of ADHD


Joseph Biederman, M.D.

Professor of Psychiatry

Massachusetts General Hospital

& Harvard Medical School


Clinical Pharmacology and Efficacy


Lesley Russell, M.R.C.P.

Senior Vice President, Worldwide Clinical Research

Cephalon, Inc.


General Safety                     


Srdjan Stankovic, M.D

Vice President, Neuroscience Clinical Research

Cephalon, Inc.




Lesley Russell, M.R.C.P.


Open Public Hearing Speakers



Questions to the Committee



FDA Back-up Slides



Cephalon Back-up Slides



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