(2)
DUBLIN, Feb. 16, 2021 /PRNewswire/ Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the completion of the rolling submission for the supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of adult patients with idiopathic hypersomnia. If approved,
Xywav will be the first and only approved treatment in the U.S. for adults with idiopathic hypersomnia.
Xywav received Fast Track designation by the FDA in September 2020 for the treatment of idiopathic hypersomnia. Jazz was granted rolling submission by FDA for this sNDA in December 2020, permitting the submission of portions of the proposed application as they were completed.