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Jazz Pharma Says FDA Committee Will Review JZP-6 To Treat Fibromyalgia - Quick Facts

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

Thursday, Jazz Pharmaceuticals, Inc. (JAZZ) said that the U.S. Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 or sodium oxybate for the treatment of fibromyalgia at a joint meeting on August 20.

In February, the FDA accepted for filing and review the New Drug Application or NDA of JZP-6 to treat fibromyalgia. The target date for the FDA to complete its review of the NDA under the Prescription Drug User Fee Act or PDUFA is October 11.

Fibromyalgia is a chronic condition characterized by widespread pain. It is believed to be a central nervous system condition, resulting from neurological changes in how the brain perceives and responds to pain. In addition to pain, the main symptoms are fatigue, disturbed sleep and morning stiffness. The exact causes of the disease are unknown.

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Global Economics Weekly Update -June 15 - June 19, 2026

June 19, 2026 16:46 ET
Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.