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FDA Approves Cephalon’s Nuvigil

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Cephalon, Inc. received approval from the FDA to market Nuvigil Tablets, 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). In OSAHS, Nuvigil is indicated as an adjunct to standard treatment(s) for the underlying obstruction. Nuvigil is the single-isomer formulation of modafinil, the API contained in Provigil Tablets, which was approved by FDA in 1998...

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