FDA Approves Apixaban Generics

The US FDA has announced the approval of 2 applications for apixaban—marking the first generic approval of a direct oral anticoagulant.

The US Food and Drug Administration (FDA) has announced the approval of 2 applications for the first generics for apixaban (Eliquis) tablets for the reducing the risk go stroke and systemic embolism in patients with nonvalvular atrial fibrillation (aFib).

With apixaban also proving efficacy in the treatment of physalis of deep vein thrombosis, the FDA approval of the generic apixaban applications to Micro Labs Limited and Mylan Pharmaceuticals Inc. represents the introduction of less expensive alternatives for patients.

“Today’s approvals of the first generics of apixaban are an example of how the FDA’s generic drug program improves access to lower-cost, safe and high-quality medicines,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “These approvals mark the first generic approvals of a direct oral anticoagulant. Direct oral anticoagulants do not require repeated blood testing.”

Following its initial approval from the FDA in 2012, apixaban has quickly become a staple in the prevention of stroke and systemic embolism. The treatment subsequently received approvals for reducing the risk ion blood clots following hip or knee replacement and treatment of deep vein thrombosis and pulmonary embolism in March and August 2014, respectively.

According to a release from the FDA, generics will be dispensed with a Medication Guide for patients. The release also pointed out that due to the increased risk of bleeding when using apixaban, physicians should counsel patients on signs and symptoms of possible bleeding.

Additionally, apixaban increases the risk of thrombotic events if a patient stops using apixaban too early. Furthermore, an FDA release pointed out patients with prosthetic heart valves should not take apixaban along with patients with atrial fibrillation that is caused by a heart valve problem.

No information on when either company that received approval of the generic apixaban applications would have the generics available for patients was available at the time of publication.