Final Agenda:  Wednesday  November 3, 1999

Psychopharmacologic Drugs Advisory Committee

 

 

 

Food and Drug Administration

Hilton, Gaithersburg, Maryland

 

8:00    Call to Order, Introductions

Carol Tamminga, M.D., Chair, PDAC

 

            Conflict of Interest Statement

Sandra Titus, Ph.D., Executive Secretary, PDAC

 

Welcome

Russell Katz, M.D., Director, Neuropharmacological Drug Products

 

Consideration of NDA 18-936 (S), Prozac® (fluoxetine hydrochloride) Eli Lilly & Co.

Proposed indication:  Treatment of Premenstrual Dsyphoric Disorder

 

8:15    FDA Overview of Issues

Thomas Laughren, M.D., Team Leader, Psychiatric Drug Products Group

 

8:30    Lilly Presentations

 

            Introduction

Gregory T. Brophy, Ph.D., Director, US Regulatory Affairs

 

Overview of PMDD

Jean Endicott, Ph.D., Department of Psychiatry, Columbia University, New York 

 

Efficacy and Safety of Fluoxetine in PMDD

Rajinder Judge, M.D., Medical Director, Neuorosciences, Eli Lilly & Co.         

 

 

10:00  Break

 

10:15  Questions from Advisory Committee to Lilly and to FDA

 

11:30  Lunch

 

1:00    Open Public Hearing

 

2:00 – 4:30 Continued Committee Discussion and Deliberation