Android app on Google Play

Bristol-Myers (BMY), Pfizer (PFE) Get CRL from FDA for ELIQUIS NDA; More Info Needed

June 25, 2012 7:32 AM EDT Send to a Friend
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ELIQUIS® (apixaban) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

The CRL requests additional information on data management and verification from the ARISTOTLE trial. Bristol-Myers Squibb and Pfizer will work closely with the FDA on the appropriate next steps for the ELIQUIS application. The FDA has not requested that the companies complete any new studies. FDA and the companies are committed to working expeditiously to address the outstanding questions and move the application forward.




You May Also Be Interested In


Related Categories

Corporate News, FDA

Add Your Comment