Food and Drug Administration
Psychopharmacological Drugs Advisory Committee
May 10, 2002
Slides
NDA 21-431: Acamprosate 333mg Tablets (Lipha Pharmaceuticals, Inc.)
Introduction, Dr. Anita Goodman, MD, Lipha htm ppt
European Development Program and Current Registration Status, Lyon France htm ppt
MOA-PK Overview, Dr. George Koob, MD , Scripps Research Inst. htm ppt
Efficacy Results from Three Pivotal Efficacy Trials, Dr. Karl Mann, MD U. of Heidelberg htm ppt
Analysis of U.S.A. Multicenter Trial Results, Dr. Barbara Mason, MD, U. of Miami htm ppt
Closing Remarks, Dr. Anita Goodman, MD, Lipha htm ppt
Outcome Predicators for Rate of Cumulative Abstinence Duration from Individual Patient Data htm ppt
Efficacy of Acamprosate: Clinical Issues Dr Celia J Winchell, MD FDA htm ppt
Statistical Perspective Acamprosate Experience, Dr. Sue-Jane Wang, PhD FDA htm ppt