Jazz Pharmaceuticals files lawsuit challenging FDA approval of Lumryz

Jazz Pharmaceuticals plc

Filed complaint in U.S. District Court for DC seeking to vacate FDA's May 1, 2023 approval of Lumryz NDA.
Alleges FDA acted outside Orphan Drug Act by granting Lumryz ODE despite Xywav's unexpired exclusivity.
Claims FDA's finding of clinical superiority (once-nightly dosing) lacks substantial evidence and is inconsistent with prior determinations.
Seeks declaration that approval was arbitrary, capricious, and in excess of statutory authority.
Jazz cannot predict outcome or impact on oxybate business.

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