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




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


            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




5:00     Adjourn