Benzinga | Apr 12, 2021 07:47AM EDT

Jazz Pharmaceuticals Announces FDA Acceptance And Priority Review Of Supplemental New Drug Application For Xywav Oral Solution In Idiopathic Hypersomnia

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation and confirmed the acceptance for substantive review of the supplemental New Drug Application (sNDA) seeking approval for XywavTM (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult patients with idiopathic hypersomnia. The sNDA will be filed by the FDA on April 13, 2021 and a PDUFA goal date for an FDA decision has been set for August 12, 2021.