FDA Approves Two Generic Versions of Apixaban

The US Food and Drug Administration has approved two companies’ applications to make generic versions of apixaban, which will be the first generic versions of any direct oral anticoagulant (DOAC) despite the drug entering the market behind two other competitors.

Micro Labs Limited and Mylan Pharmaceuticals Inc. will be allowed to make their generic versions, having already demonstrated that they are bioequivalent to the branded version of apixaban (Eliquis; Bristol-Myers Squibb), which was first approved in 2012 to reduce the risk of stroke and systemic embolism in patients with nonvalvular A-fib. The drug has since gained indications for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone hip or knee replacement surgery and for the treatment of DVT and pulmonary embolism (PE), and the reduction in risk of DVT and PE, following initial therapy.

Apixaban was the third DOAC—following dabigatran (Pradaxa; Boehringer Ingelheim) in 2010 and rivaroxaban (Xarelto; Bayer/Janssen) in 2011—to gain approval in the United States. Edoxaban (Savaysa; Daiichi Sankyo) entered the market in 2015.

“Apixaban will be dispensed with a medication guide for patients that provides instructions on its use and drug safety information. Healthcare professionals should counsel patients on signs and symptoms of possible bleeding,” the FDA said in announcing the generic approvals.

The FDA has granted tentative approval to three companies to manufacture generic versions of dabigatran and to two companies to make generic rivaroxaban.