Aurobindo Receives FDA Approval for Apixaban Tablets, 2.5 mg and 5 mg
Published: May 26, 2023
East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Apixaban Tablets, 2.5 mg and 5 mg. Aurobindo Pharma’s Apixaban Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), Eliquis Tablets manufactured by Bristol-Myers Squibb Company.
Apixaban Tablets are indicated for:
- To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
- The prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery
- The treatment of DVT
- The treatment of PE
- To reduce the risk of recurrent DVT and PE following initial therapy.
