FDA issues approvable letter for Nuvigil

Cephalon has landed conditional FDA approval for its sleep drug Nuvigil. Prior to full approval, the drug developer will have to agree on the label's wording. Some analysts characterized the announcement as something of a setback for Cephalon, which is already engaged in talks with the FDA over formal acceptance of Sparlon, a high-dose version of Provigil. Cephalon has been seeking FDA approval for Nuvigil as a treatment for excessive sleepiness due to narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift-work sleep disorder.

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