Food and Drug Administration

Psychopharmacological Drugs Advisory Committee

May 10, 2002


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