FDA approves first generics of Eliquis

The US Food and Drug Administration has approved two applications for the first generics of Bristol-Myers Squibb (NYSE: BMY) and Pfizer’s (NYSE: PFE) Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

The applications were submitted by India’s Micro Labs Limited and Netherlands-incorporated Mylan (Nasdaq: MYL). Pfizer is in the process of merging its generic products Upjohn business with that of Mylan.

Eliquis, which generated third-quarter 2019 revenues for B-MS of $1.93 billion, 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. Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy.