D.C. Circuit affirms FDA approval of LUMRYZ, rejecting Jazz's challenge

AVADEL PHARMACEUTICALS PLC

On June 27, 2025, D.C. Circuit unanimously upheld LUMRYZ approval.
Affirms October 2024 summary judgment in favor of Avadel and FDA.
Jazz Pharmaceuticals' APA lawsuit against FDA approval fully rejected.
Legal risk of LUMRYZ approval being set aside now removed.
Avadel can continue commercializing LUMRYZ without appellate threat.

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