Pharmaceuticals Search Engine [selected websites]

Blog Archive

Tuesday, April 20, 2010

Cephalon : Complete Response Letter for NUVIGIL for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

CephalonMarch 29, 2010 - Cephalon, Inc. (Nasdaq: CEPH) announced the company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for its supplemental new drug application for NUVIGIL(R) (armodafinil) Tablets [C-IV] in the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel.

As the first company to study a treatment option to improve wakefulness associated with jet lag disorder, Cephalon worked closely with the FDA to design a special protocol assessment (SPA) that would evaluate the experience of a typical eastbound airline traveler... Cephalon's Press Release -