Cephalon's Nuvigil gets tentative OK from FDA

US drugmaker Cephalon has received an approvable letter, together with draft labeling from the Food and Drug Administration for its New Drug Application for Nuvigil (armodafinil) tablets for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSAHS) and shift-work sleep disorder (SWSD).

The draft labeling includes a proposed bolded warning section that characterizes the potential occurrence of skin rash and hypersensitivity in patients taking modafinil and armodafinil and Cephalon's first-generation wakefulness drug Provigil (modafinil).

Among other things, the agency has requested that the company provides a standard safety update from clinical trials conducted since the last update in June 2006, and introductory promotional materials to be used for the product. The company's response will be submitted within 30 days and will be considered a Class I response; the agency is expected to complete its review within 60 days thereafter and has not requested any additional studies prior to final approval of Nuvigil.