ARTICLE | Clinical News

Sodium oxybate regulatory update

October 18, 2010 7:00 AM UTC

FDA issued a complete response letter for an NDA from 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, the proposed REMS, concentration and trade name. Jazz requested a meeting with FDA to discuss and clarify the letter. ...