FDA accepts resubmitted Eliquis NDA

Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) said FDA accepted a resubmitted NDA for Eliquis apixaban to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The new PDUFA date is March 17, 2013. Bristol-Myers said the resubmission included responses to FDA's June complete response letter, which asked for additional information on data management and verification from the Phase III ARISTOTLE trial of the direct Factor Xa inhibitor. ...