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FDA to review Nuvigil for jet lag disorder treatment

Written by: David Castillo on September 30th, 2009
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FDA to review Nuvigil for jet lag disorder treatment  | read this item

The U.S. Food and Drug Administration (FDA) is set to review Cephalon’s Nuvigil sleep disorder drug for treatment of jet lag, the drug manufacturer announced last Thursday.

The FDA is expected to make its decision regarding the product by the end of December 2009.

The regulator is reviewing whether Nuvigil is a qualified treatment for “improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel,” Cephalon described.

Currently, there are no FDA-approved treatments for jet lag disorder.

Under priority review status, the FDA will make its decision whether to approved the drug or not within a six-month period.

Source: Reuters

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