ICI Pharmaceuticals' Diprivan (propofol)

Executive Summary

On July 19, FDA, ICI reps and a member of the Anesthetic and Life Support Drugs Advisory Committee will hold a "mini-NDA Day" to discuss the supplemental NDA (No. 19-627) for Diprivan emulsion for intravenous injection for sedation during monitored anesthesia care. FDA originally had planned to review the supplement, which was filed in March 1990, at the committee's July 18 meeting; however, that meeting was cancelled because it was decided that a full committee discussion was unnecessary. Diprivan is currently marketed for induction and maintenance of anesthesia.