Food and Drug Administration

Anesthetics and Life Support Drugs

November 18, 2003

Slides

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Inapsine: Basis for Approval, Dr. Arthur Simone, MD, PhD, FDA (HTM) (PPT)

Droperidol Since 2001 FDA Risk Assessment, Dr. Nancy Chang, MD, FDA (HTM) (PPT)

Backup Information, Dr. Nancy Chang, MD, FDA (HTM) (PPT)

Prospective Controlled Study of QTc Prolongation by Droperidol in Healthy Volunteers, Dr. Mehul Desai, MD, FDA (HTM) (PPT)

Drug-Induced QT Interval Prolongation - Why is it of Concern?, Dr. Marek Malik, PhD, MD,St. George's Hospital Medical School, England (HTM) (PPT)

Droperidol Study Proposals, Dr. Lex Schultheis, MD, PhD, FDA (HTM) (PPT)