Organon/Sanofi-Synthelabo Arixtra "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Fondaparinux is deemed "approvable" Aug. 15 for prevention of venous thromboembolic events after orthopedic surgery. Organon submitted the NDA Feb. 15 and received priority review. Arixtra, which will be co-marketed in the U.S. by Sanofi-Synthelabo, is in Phase III studies for treatment of venous thrombosis and pulmonary embolism and in Phase II trials for treatment of arterial thrombosis