Posted by Michael Wonder on 23 Dec 2016
Portola Pharmaceuticals announces FDA accepts new drug application for priority review and EMA validates marketing authorisation application for oral, factor Xa inhibitor anticoagulant betrixaban
23 December 2016 - Portola Pharmaceuticals today announced that the U.S. FDA accepted Portola's new drug application granting priority review for betrixaban, an oral, once-daily factor Xa inhibitor anticoagulant, for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
The application for betrixaban, an FDA-designated fast track investigational drug, was deemed sufficiently complete to permit a substantive review and has been given a Prescription Drug User Fee Act action date of 24 June 2017.
