Cephalon expects Provigil advisory committee
Executive Summary
Cephalon expects Provigil sNDA for treatment of excessive sleepiness associated with disorders of sleep and wakefulness will receive FDA advisory committee review "probably...in the later half of the year," CEO Frank Baldino says May 7. FDA's Peripheral & Central Nervous System Drugs Advisory Committee is scheduled to meet July 18, but expects to hold other meetings. The company filed the modafinil sNDA in December and expects FDA action in the fourth quarter...