ARTICLE | Clinical News

Nuvigil armodafinil regulatory update

November 1, 2010 7:00 AM UTC

FDA approved a REMS for Nuvigil armodafinil from Cephalon to inform patients about the potential risks associated with its use, including serious skin rash and hypersensitivity reactions. The REMS consists of a medication guide, communication plan, Dear Healthcare Professional letter, prescriber brochure, pharmacist action letter, dedicated REMS internet site and timetable for submission of assessments. Cephalon said the label, which the company is updating to include the medication guide, already warns of the risks. Nuvigil is approved in the U.S. to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. ...