Cephalon wins U.S. backing for sleep disorder drug

Cephalon Inc. won U.S. approval to sell a longer-acting version of the sleep disorder drug Provigil, its best-selling product.

The Food and Drug Administration cleared the new formula, called Nuvigil, as a treatment for sleepiness related to narcolepsy, shift work and sleep apnea, agency spokeswoman Sandy Walsh said Friday in an e-mail. Company spokeswoman Jen Antonacci didn't immediately return a voice-mail message seeking comment.

Nuvigil's approval may help Cephalon, which makes several products in Salt Lake City, fend off potential generic competition to Provigil, which generated about $728 million in sales last year. U.S. antitrust regulators subpoenaed the company in March demanding details on agreements signed with four generic drugmakers to postpone sales of lower-cost copies of Provigil until 2012.

"We view approval as a transformative event for Cephalon given Nuvigil could extend exclusivity on Cephalon's rapidly growing wakefulness franchise to 2023," said Eric Schmidt, an analyst with Cowen & Co. in New York, in a March 23 note.