BioCentury
ARTICLE | Clinical News

Eliquis apixaban regulatory update

March 24, 2014 7:00 AM UTC

FDA approved an sNDA for Eliquis apixaban for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone hip or knee replacement surgery. An sNDA is also under FDA review for Eliquis to treat DVT and pulmonary embolism (PE) and reduce risk of recurrent DVT and PE, with an Aug. 25 PDUFA date (see BioCentury, Jan. 6). Eliquis is approved in the U.S., EU, Canada, Iceland, Norway, Japan and other countries to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). ...