Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

Peripheral and Central Nervous System Drugs Advisory Committee

September 24, 2003

Holiday Inn

8120 Wisconsin Avenue, Bethesda, Maryland

Draft AGENDA

8:00 Call to Order and Opening Remarks Claudia Kawas, MD

Chair

Introduction of Committee

Conflict of Interest Statement Anuja M. Patel, M.P.H.

Executive Secretary, FDA

Discussions on new drug application (NDA) application 21-487, memantine hydrochloride, Forest Laboratories, Inc., indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

8:15 Opening Remarks FDA

Overview of Issues

8:45 Sponsor Presentations Forest Laboratories Incorporated

· Introduction and Memantine Overview

· Memantine Pharmacology

· Efficacy Data

· Summary and Risk/Benefit

10:45 FDA Presentation

11:15 Questions from Committee to FDA

12:00 Lunch

1:00 Open Public Hearing

2:00 Continuation of Committee Discussion and Response to FDA Questions

Break

5:00 Adjourn