Cephalon announced label update completion

Cephalon has announced that it has completed revisions to the label for Provigil tablets, its wake-promoting agent.

The US pharmaceutical company finalised the label and shared it with healthcare professionals as part of changes announced earlier this year to make the Provigil label consistent with the Nuvigil tablets label which had already been approved and made available by the US Food and Drug Administration (FDA) in June 2007.

Cephalon is also undergoing a development programme evaluating the use of Nuvigil as a treatment for serious psychiatric and neurological medical condition with the company planning a commercial launch of Nuvigil once additional clinical data has been amassed.

Provigil and Nuvigil are both indicated to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), shift work sleep disorder and narcolepsy.

Earlier this week, Cephalon communicated with healthcare professionals to clarify the appropriate patient selection, dosing and administration for Fentora.