Avadel Pharmaceuticals plc has announced a significant regulatory decision concerning its product, LUMRYZ. On June 27, 2025, the United States Court of Appeals for the District of Columbia Circuit upheld the U.S. District Court's ruling, affirming the FDA's approval of LUMRYZ. This decision comes after Jazz Pharmaceuticals, Inc. appealed a previous court ruling that granted summary judgment in favor of the FDA and Avadel Pharmaceuticals, rejecting Jazz's claim that the FDA's approval was unlawful. This marks a crucial victory for Avadel Pharmaceuticals, ensuring that LUMRYZ remains approved for its intended use.
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