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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 to improve wakefulness.

Cephalon’s clinical program will evaluate the use of Nuvigil as a treatment for medical conditions such as bipolar depression, cognition associated with schizophrenia, excessive sleepiness in medical conditions such as Parkinson’s disease, and fatigue in patients who are being treated for cancer. The company currently plans a commercial launch of Nuvigil pending additional clinical data.

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