Thursday, September 27, 2012

USFDA accepts resubmitted NDA for Eliquis

In response to CR issued by the USFDA, Bristol Myers and Pfizer resubmitted the NDA. The resubmitted NDA has been accepted and the new PDUFA data for Eliquis is now March 17th 2013. The complete response letter issued earlier requested additional information on data management and verification. Eliquis is a new generation oral anticoagulant intended for the treatment of Stroke Prevention in Atrial Fibrillation. It is the only new generation oral anticoagulant to have demonstrated superiorty in terms of  net clincial benefit compared to warfarin