Posted by Michael Wonder on 16 Feb 2021
Jazz Pharmaceuticals completes submission of supplemental new drug application for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for idiopathic hypersomnia
16 February 2021 - Jazz Pharmaceuticals today announced the completion of the rolling submission for the supplemental new drug application to the U.S. 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.
