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Jazz Pharmaceuticals Announces FDA Acceptance of its New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia
Date:2/18/2010

PALO ALTO, Calif., Feb. 18 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia.  Based on a standard 10-month review, the target date for the FDA to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010.  

The submission is based on a comprehensive clinical development program including results from two Phase III clinical trials. In both trials, sodium oxybate significantly decreased pain and fatigue as well as improved daily function, patient global impression of change, and sleep quality. Sodium oxybate was generally well tolerated, with the majority of adverse events reported being mild t
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