The US Food and Drug Administration has extended the action date for Cephalon's review of the new drug application (NDA) for Nuvigil (armodafinil) tablets [C-IV] to improve wakefulness in patients suffering from excessive sleepiness associated with narcolepsy, shift work sleep disorder (SWSD) and obstructive sleep apnea/hypopnea syndrome (OSA/HS) to April 30, 2006.

"We will continue to work closely with the FDA to assist them in completing their review of our application in a timely manner and do not anticipate any further delays beyond the April 30 action date," said Dr. Paul Blake, executive vice president, worldwide medical and regulatory operations, Cephalon Inc.

According to a company release, a NDA for Nuvigil was filed with the FDA on March 31, 2005. The original action date under the Prescription Drug User Fee Act (PDUFA) for the Nuvigil NDA was January 31, 2006. At the FDA's request, the company submitted additional information to FDA in October 2005. The FDA has informed the company that this submission has been classified as a major amendment to the NDA, which enables the FDA to extend the action date by 90 days to provide the agency time for a full review of the submission.

Nuvigil is a single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in Provigil (modafinil) tablets [C-IV].

Cephalon Inc. is an international biopharmaceutical company that discovers, develops and markets innovative products to treat sleep and neurological disorders, cancer and pain.