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PALO ALTO, Calif. The Food and Drug Administration has turned down an application from a company seeking approval for a drug to treat fibromyalgia.
Jazz Pharmaceuticals announced Monday that the FDA had given it a complete response letter for the drug JZP-6 (sodium oxybate), citing a need for additional clinical studies and issues concerning the appropriate patient population, ensuring safe use, a proposed risk evaluation and mitigation strategy, and others.
The FDA delivers a complete response letter to a company seeking approval for a drug when it finishes reviewing the application but questions remain that preclude final approval.