Jazz Loses Bid to Revive Suit Over FDA Rival Sleep Drug Approval

Jazz Pharmaceuticals Inc. failed to convince the D.C. Circuit that the FDA violated a federal law when the agency approved a rival version of its sleep drug Xywav, facing another blow in its fight to show the two drugs at issue are the same.

The US Court of Appeals for the District of Columbia Circuit affirmed Friday a lower court decision that the Food and Drug Administration didn’t break orphan drug exclusivity when it approved Avadel CNS Pharmaceuticals LLC’s Lumryz, a rival product of Jazz’s narcolepsy drug Xywav.

The question before the appeals court was whether Avadel’s and Jazz’s drugs ...