Daily International Pharma Alert

Cephalon has finalized revisions to the label for Provigil tablets, its product to improve wakefulness in adults with obstructive sleep apnea/hypopnea syndrome, shift work sleep disorder and narcolepsy.

Cephalon said these changes were necessary to make the Provigil (modafinil) label consistent with the Nuvigil (armodafinil) label approved by the FDA in June. Nuvigil is the single isomer formulation of modafinil.

Cephalon’s ongoing development program is evaluating Nuvigil as a treatment for serious psychiatric and neurological medical conditions. The company said it plans a commercial launch of Nuvigil once additional clinical data has been amassed.