The FDA announced it approved two applications for the first generic versions of apixaban tablets to reduce risk for stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Apixaban is also indicated for the prophylaxis of deep vein thrombosis, a risk factor for pulmonary embolism, in patients who have undergone hip or knee replacement surgery, according to a press release from the agency.
Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in risk for recurrent DVT and PE following initial therapy, according to the release.
Apixaban was previously available in the U.S. only under the brand name Eliquis (Bristol-Myers Squibb/Pfizer). The approvals for generic versions were granted to Micro Labs Ltd. and Mylan Pharmaceuticals Inc.
“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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the release. “These approvals mark the first generic approvals of a direct oral anticoagulant. Direct oral anticoagulants (blood thinners) do not require repeated blood testing.”
The FDA release also included several potential risks for the use of apixaban:
- Increased risk for thrombotic events or strokes if a patient stops using apixaban too early;
- epidural or spinal hematomas may occur in patients treated with apixaban receiving neuraxial anesthesia or undergoing spinal puncture; and
- patients with prosthetic heart valves should not take apixaban, nor should patients with AF caused by a heart valve problem.
According to the release, bleeding, including life-threatening and fatal bleeding, is the most serious risk associated with apixaban.
