Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval

A pharmaceutical manufacturer known for its sleep medicines will argue Friday before a federal district court that the FDA violated an orphan drug law when it approved a rival product.

Jazz Pharmaceuticals PLC will take to the US District Court for the District of Columbia to argue its case against the Food and Drug Administration on whether the agency violated the Orphan Drug Act when it approved Avadel CNS Pharmaceuticals LLC’s Lumryz, a rival product of Jazz’s narcolepsy drug Xywav.

At issue before the court is whether the FDA’s interpretation of “same drug” applies to Xywav and Lumryz. Jazz argues ...