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



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



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