Jazz Pharmaceuticals Announces FDA Acceptance Of Its New Drug Application For JZP-6 (sodium Oxybate) For The Treatment Of Fibromyalgia
Submitted by MedicalReplies on Saturday, 20 February 2010No Comment
Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced 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…
View original post here:
Jazz Pharmaceuticals Announces FDA Acceptance Of Its New Drug Application For JZP-6 (sodium Oxybate) For The Treatment Of Fibromyalgia
Leave your response!