FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANESTHETIC & LIFE SUPPORT DRUGS ADVISORY

COMMITTEE MEETING

AGENDA

November 18, 2003

Holiday Inn, Gaithersburg, Maryland

8:00 a.m. Call to Order Nathaniel Katz, M.D., M.P.H., Chair, ALSDAC

Terese Horlocker, M.D., Co-Chair

Introduction of Committee

Conflict of Interest Statement Johanna Clifford, M.S., RN, BSN

Executive Secretary, ALSDAC

8:15 a.m. Opening Remarks

8:30 a.m. Inapsine Basis for Approval

8:45 a.m. Droperidol since 2001:

FDA Risk Assessment

9:30 a.m. Break

9:45 a.m. Prospective Controlled Study of QTc

Prolongation by Droperidol in Healthy

Volunteers

10:15 a.m. QTc Prolongation: Controversies,

Consensus, Case Histories

11:30 a.m. Droperidol Study Proposals

12:15 p.m. Lunch

1:15 p.m. Open Public Hearing

2:15 p.m. Break

2:30 p.m. Charge to the Committee

Questions for Discussion

4:30 p.m. Adjourn