Jazz Gets Complete Response for Fibromyalgia Treatment Rekinla

The FDA handed Jazz Pharmaceuticals a complete response letter for its fibromyalgia drug Rekinla, requesting additional clinical trials, more information on patient selection and revisions to the risk evaluation and mitigation strategy. New clinical studies would evaluate safety in patients who may be taking concomitant medications, Bruce Cozadd, Jazz chairman and CEO said Monday in an investor call. Jazz has requested a meeting with the FDA to discuss the letter and evaluate potential next steps, Cozadd added.
Drug Industry Daily