FDA Panel Warns Of Provigil Safety For Kids

Law360, New York (November 29, 2007, 12:00 AM EST) -- A Food and Drug Administration panel on Wednesday pushed for a stronger warning label that would explicitly tell doctors that Cephalon Inc.'s sleep disorder drug Provigil is not recommended for children.

Provigil, also known as the chemical modafinil, is one of Cephalon's best-selling products. The drug is currently approved by the FDA for the treatment of narcolepsy, shift work sleep disorder and obstructive sleep apnea.

But Provigil has also been widely prescribed for a variety of off-label uses, including fatigue, depression and attention deficit hyperactivity disorder....
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