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Nuvigil Approval History

  • FDA approved: Yes (First approved June 15th, 2007)
  • Brand name: Nuvigil
  • Generic name: armodafinil
  • Dosage form: Tablets
  • Company: Cephalon, Inc.
  • Treatment for: Narcolepsy

Nuvigil (armodafinil) is a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder (SWSD).

Development History and FDA Approval Process for Nuvigil

DateArticle
Jun 18, 2007Approval Cephalon Receives FDA Approval of Nuvigil for the Treatment of Excessive Sleepiness Associated with Three Disorders
Apr  2, 2007Cephalon Provides Update Related to Nuvigil New Drug Application
Nov  7, 2006Cephalon Inc. Granted Composition of Matter Patent Covering Nuvigil
May  1, 2006Cephalon Receives Approvable Letter for Nuvigil
Mar 31, 2005Cephalon Files New Drug Application for Nuvigil

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