Jazz Pharmaceuticals, Inc. (JAZZ) Friday said that the Joint Advisory Committee of the U.S. Food and Drug Administration, including the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 20-2 that the benefit and risk balance did not support the approval of JZP-6 for the treatment of fibromyalgia with the currently proposed Risk Evaluation Mitigation Strategy.
Chief Executive Officer Bruce Cozadd said, "While we are disappointed with the recommendation of the Joint Advisory Committee, we plan to work closely with FDA on the continuing review of our new drug application."
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