Food and Drug Administration

Psychopharmacologic Drugs Advisory Committee Meeting

May 10, 2002

Briefing Document for Acamprosate 333gm Tablets 
Calcium acetylhomotaurinate (acamprosate, Campral) 

Briefing Information

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Briefing Document for Acamprosate 333gm Tablets  pdf

Overview  htm  doc  pdf

Clinical Background Materials  doc pdf

Statistical Review and Evaluation  htm  doc  pdf