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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.