Jazz Pharmaceuticals plc (NASDAQ: JAZZ) has filed suit against the FDA for approving Avadel Pharmaceuticals Plc's (NASDAQ: AVDL) Lumryz (sodium oxybate extended-release) for cataplexy or excessive daytime sleepiness in adult patients with narcolepsy. Jazz says Avadel's Lumryz is an extended-release reformulation of its high sodium oxybate product Xyrem for narcolepsy. Jazz argues that the approval was unlawful and violates the orphan drug exclusivity of Xywav. In an SEC filing, Jazz alleges that