Food and Drug Administration

Peripheral and Central Nervous Sytem Drugs Advisory Committee

September 24, 2003

Briefing Information


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.

Memantine HCI (NDA 21-487) Briefing Document, Forest Laboratories, Inc. (PDF)

Memantine Clinical Data Quick Reference (PDF)

FDA Memorandum Regarding the Use of Memantine in Patients With Moderate to Severe Dementia of the Alzheimer's Type (PDF)

FDA Safety Review, Dr. Gerard Boehm, MD, MPH (PDF)

FDA Efficacy Review, Dr. Ranjit Mani, MD (HTM) (PDF) (Word)

FDA Statistical Review, Dr. Russell Katz, MD, (HTM) (PDF) (Word)

Bibliography (HTM) (PDF) (Word)