Posted by Michael Wonder on 12 Apr 2021
Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental new drug application for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in idiopathic hypersomnia
12 April 2021 - Final FDA decision anticipated by 12 August.
Jazz Pharmaceuticals today announced that the U.S. FDA has granted priority review designation and confirmed the acceptance for substantive review of the supplemental new drug application seeking approval for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult patients with idiopathic hypersomnia.
The supplemental new drug application will be filed by the FDA on 13 April 2021 and a PDUFA goal date for an FDA decision has been set for 12 August 2021.
