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Nuvigil FDA Approval History

FDA Approved: Yes (First approved June 15, 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 timeline for Nuvigil

Jun 18, 2007Approval Cephalon Receives FDA Approval of Nuvigil for the Treatment ofExcessive 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

Further information

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