FDA Approves Generic Versions of Apixaban

December 30, 2019

The approvals were granted to generic apixaban applications from Micro Labs Limited and Mylan Pharmaceuticals Inc.

Officials with the FDA recently approved 2 applications for the first generic versions of apixaban (Eliquis) tablets, according to a news release.

The approvals were granted to generic apixaban applications from Micro Labs Limited and Mylan Pharmaceuticals Inc.

Apixaban was initially approved in 2012 for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). It is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery, as well as for the treatment of DVT and PE and the reduction of the risk of recurrent DVT and PE following initial therapy.

“Today’s approval 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 a statement. “These approvals mark the first generic approvals of a direct oral anticoagulant. Direct oral anticoagulants (blood thinners) do not require repeated blood testing.”

Patients who stop using apixaban too early may be at an increased risk of thrombotic events, according to the FDA. Additionally, epidural or spinal hematomas may occur in patients treated with apixaban who are receiving neuraxial anesthesia or undergoing spinal puncture.

Apixaban will be dispensed with a Medication Guide for patients that provide instructions on its use and drug safety information. Health care professionals should counsel patients on signs and symptoms of possible bleeding, according to the FDA.  

References:

FDA approves first generics of Eliquis [news release]. FDA's website. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-eliquis. Accessed December 30, 2019.