Food and Drug Administration

Peripheral and Central Nervous Sytem Drugs Advisory Committee

September 25, 2003

Briefing Information


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.

Provigil® (modafinil) Tablets (C-IV) Supplemental NDA (HTM) (PDF) (Word)

FDA Memorandum Regarding the Use of Provigil (modafinil) Tablets in the Treatment of Excessive Sleepiness Associated With Disorders of Sleep and Wafefulness (HTM) (PDF) (Word)