Jazz Disputes FDA’s Approval Of Lumryz Over Xywav’s Orphan Exclusivity, Citing Lack Of Comparative Study

Lawsuit argues FDA wrongly determined that Avadel’s Lumryz is ‘clinically superior’ to Xywav because of once-nightly dosing. FDA’s Division of Neurology revised its initial opinion based on views of CDHR’s sleep team and additional input from the agency’s orphan drug office.