FDA questions Nuvigil’s application to jet lag | 
The US Food and Drug Administration (FDA) had several questions last Monday concerning Cephalon’s effort to get Nuvigil approved as a treatment for jet lag.
The regulator questioned the strength behind Cephalon’s application. The FDA concerned about the subjective assessments reported by the patients, who were tested on to determine the effectiveness of the drug.
There will be another meeting between Cephalon and the FDA in the upcoming months.
Nuvigil is an improved version of Cephalon’s main product—Provigil. It was introduced last year, and has been approved by the FDA as a treatment that improves sleep disorder conditions, including sleep apnea, shift work, and narcolepsy.
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