By Denny Jacob
Jazz Pharmaceuticals on Thursday said its subsidiary filed a complaint alleging that the Food and Drug Administration unlawfully approved Avadel Pharmaceuticals’ new drug application for Lumryz.
The biopharmaceutical company said in a regulatory filing, which outlined their complaint, that the FDA acted outside of its authority under the Orphan Drug Act. Jazz Pharmaceuticals said its product Xywav had orphan drug exclusivity. It said that the FDA approved Lumryz’s new drug application and granted it orphan drug exclusivity based on its own findings that it boosts patient care, and is therefore clinically superior to Xywav and another drug it produces, Xyrem. Both drugs treat cataplexy, or excessive daytime sleepiness, in adults with narcolepsy.
Jazz Pharmaceuticals described Lumryz as an extended-release reformulation of Xyrem.
The Ireland-based company said among the complaint’s allegations are that the FDA acted without lawful basis when it determined that the dosing regimen for Lumryz makes a major contribution to patient care.
The complaint was filed in the United States District Court for the District of Columbia.
Write to Denny Jacob at [email protected]
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