Decision Delayed on Cephalon's Nuvigil by FDA

Decision Delayed on Cephalon's Nuvigil by FDA

As confirmed by the drug manufacturer on Monday, the US Food and Drug Administration has delayed its approval status on Cephalon Inc's medicine Nuvigil, which has now been seeking approval to treat constant sleepiness caused by jet lag. The decision has been push forward by 3 months.

In a move which surprised everyone, the FDA, earlier this year, granted a "priority review" to the drug maker's application for approval, and declared that the final decision will come through on December 29 on whether or not Nuvigil is fit enough to be marketed under current circumstances.

But now the regulator has informed the pharma company that it needs more time to aptly review the drug and has extended the decision date to March 29, 2010.

Currently, the drug has been approved for patients who suffer from "excessive sleepiness due to sleep apnea, narcolepsy or shift work disorder", and the company is looking to now market it specifically "for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel".

Cephalon, in after-market trading, dropped 60 cents to trade at a new low of $59.15.

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