Chephalon finalizes label revisions for Provigil

FRAZER, Pa. Cephalon has finalized its revisions to its label for its drug Provigil, which is used to improve wakefulness in adults with obstructive sleep apnea/hypopnea syndrome, shift work sleep disorder and narcolepsy.

These changes were made necessary to make Provigil’s label consistent with Nuvigil’s label, which was approved, by the Food and Drug Administration in June. Nuvigil is a single isomer formulation of the key ingredient found in Provigil.

The company said it plans a commercial launch of Nuvigil once additional clinical data has been amassed.