FDA Approves Anti-Clotting Drug Eliquis for Some Atrial Fibrillation Patients

The Food and Drug Administration Dec. 28, 2012, said that it approved the anti-clotting drug Eliquis (apixaban), which is an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem.

The agency said Eliquis is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and Pfizer Inc., based in New York.

The approval followed FDA’s rejection of the drug, in a complete response letter, issued in June. At that time, FDA asked for additional clinical trial data (10 PLIR 846, 6/29/12