ARTICLE | Company News

FDA wants more data on Jazz's JZP-6

October 12, 2010 12:53 AM UTC

FDA issued a complete response letter for an NDA from Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ) for sodium oxybate ( JZP-6) to treat fibromyalgia. According to Jazz, FDA's letter discussed issues such as the need for additional clinical studies, the appropriate patient population, methods for ensuring safe use, and the proposed REMS, concentration and trade name. Jazz requested a meeting with the FDA to discuss and clarify the letter. ...