Avadel Pharmaceuticals Triumphs as D.C. Court of Appeals Upholds FDA Approval of LUMRYZ

Reuters
06-28
Avadel Pharmaceuticals Triumphs as D.C. Court of Appeals Upholds FDA Approval of LUMRYZ

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Avadel Pharmaceuticals plc published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001104659-25-063606), on June 27, 2025, and is solely responsible for the information contained therein.

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