Cephalon Provigil for wakefulness

Executive Summary

Cephalon's Provigil (modafinil) sNDA to improve wakefulness in patients with excessive sleepiness associated with disorders of sleep and wakefulness will be reviewed by FDA's Peripheral & Central Nervous System Drugs Advisory Committee on Sept. 25. Cephalon filed the sNDA for the new indication Dec. 20, 2002; Provigil is currently approved for sleepiness associated with narcolepsy. The meeting will be held at the Holiday Inn in Bethesda, Md. beginning at 8 a.m. [To 1watch a webcast of this meeting, visit FDAAdvisoryCommittee.com]...