Cephalon says FDA decision on Nuvigil as treatment for jet lag is now due March 29
By APMonday, December 21, 2009
FDA extends Nuvigil jet lag review by 3 months
FRAZER, Pa. — The Food and Drug Administration needs more time to review Cephalon Inc.’s drug Nuvigil as a treatment for jet lag, Cephalon said Monday.
Cephalon is seeking approval to market Nuvigil for the treatment of tiredness in jetlagged patients. The company said the FDA extended its review by three months, and a decision is now due by March 29, 2010. Cephalon said it had submitted new information about Nuvigil, and the agency decided it needed more time to review its application.
The FDA’s decision had been expected by Dec. 29.
Nuvigil, also called armodafinil, is on the market as a treatment for narcolepsy, excessive sleepiness caused by sleep apnea, and changes in work schedule. Cephalon is hoping to apply for approval in other indications over the next five years.
In aftermarket trading, Cephalon shares lost 60 cents to $59.15.
