Jazz Pharma Loses Lawsuit Over FDA Approval of Rival Sleep Drug

A federal judge ruled the FDA didn’t break orphan drug exclusivity when it approved a rival version of Jazz Pharmaceuticals PLC’s sleep drug Xywav.

Judge Amit P. Mehta of the US District Court for the District of Columbia agreed with the Food and Drug Administration when the agency said it had the authority to approve Avadel CNS Pharmaceuticals LLC’s Lumryz, a rival product of Jazz’s narcolepsy drug Xywav.

The FDA didn’t err in determining that Lumryz and Xywav are not the “same drug,” didn’t inexplicably depart from a “comparable safety” policy because there is no such policy, and didn’t act ...