JZP-6 to be reviewed at joint meeting for treatment of fibromyalgia

Jun 25 2010

Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010.

In February 2010, the FDA accepted for filing and review the New Drug Application (NDA) of JZP-6 (sodium oxybate) for the treatment of fibromyalgia.   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.  

Source: http://www.jazzpharma.com/