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Article: Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder.
- Article from:
- PR Newswire
- Article date:
- September 24, 2009
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FRAZER, Pa., Sept. 24 /PRNewswire-FirstCall/ -- Cephalon, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted a priority review for its supplemental New Drug Application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV], which was filed in June of this year. The FDA decision on approval of NUVIGIL as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel is expected by December 29, 2009. There currently is no FDA-approved treatment for jet lag disorder.
The NUVIGIL sNDA is based on data from a Phase III pivotal study that evaluated the efficacy and safety of ...