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
(PPT)
(HTM) |
Glenn
Mannheim, M.D.
Medical
Officer, Division of Psychiatry Products CDER, FDA |
Modafinil
for the Treatment of ADHD
(PPT)
(HTM) |
Paul
J. Andreason, M.D.
Deputy
Director, Division of Psychiatry Products
CDER,
FDA |
Serious
Adverse Cutaneous Reactions to Drugs
(PPT)
(HTM)
|
Michael
E. Bigby, M.D.
Associate
Professor
Beth Israel Deaconess Medical
Center |
Cephalon Presentation
(PPT)
(HTM)
|
|
Introduction
|
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.
|
Benefit-Risk/Conclusions
|
Lesley
Russell, M.R.C.P. |
Open Public Hearing Speakers
(PPT)
(HTM) |
|
Questions to the Committee
(PPT)
(HTM) |
|
FDA Back-up Slides
(PPT)
(HTM) |
|
Cephalon Back-up Slides
(PPT)
(HTM) |
|