Mylan gets U.S. FDA approval for Eliquis generic

U.S. Food and Drug Administration grants approval to Mylan Pharmaceuticals (MYL +0.7%) and Micro Labs for the first generics of Bristol-Myers Squibb’s (BMY -0.3%) Eliquis (apixaban) blood thinner for two applications.

The first application is to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

It’s also indicated to help prevent deep vein thrombosis, which may lead to pulmonary embolism, or blood clots in the lungs, in patients who have undergone hip or knee replacement surgery.

 “These approvals mark the first generic approvals of a direct oral anticoagulant,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “Direct oral anticoagulants (blood thinners) do not require repeated blood testing.”

Previously: FDA tentatively approves Mylan’s generic Eliquis (July 10)

https://seekingalpha.com/news/3528264-mylan-gets-u-s-fda-approval-for-eliquis-generic