Eliquis FDA Approval History
FDA Approved: Yes (First approved December 28, 2012)
Brand name: Eliquis
Generic name: apixaban
Dosage form: Tablets
Company: Bristol-Myers Squibb Company and Pfizer Inc.
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery
Eliquis (apixaban) is a factor Xa inhibitor anticoagulant indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone hip or knee replacement surgery.
Development timeline for Eliquis
Date | Article |
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Sep 23, 2022 | Artivion Follows Recommendation to Stop PROACT Xa Clinical Trial |
Aug 21, 2014 | Approval FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism |
Mar 18, 2014 | Approval FDA Approves Eliquis to Reduce Risk of Blood Clots Following Hip Or Knee Replacement Surgery |
Jul 11, 2013 | FDA Accepts Eliquis (apixaban) Supplemental New Drug Application for Review for Prophylaxis of Deep Vein Thrombosis Following Hip Or Knee Replacement Surgery |
Dec 28, 2012 | Approval FDA Approves Eliquis to Reduce the Risk of Stroke, Blood Clots in Patients with Non-Valvular Atrial Fibrillation |
Sep 26, 2012 | FDA Acknowledges Receipt of Resubmission of the Eliquis (apixaban) New Drug Application to Reduce the Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation |
Jun 25, 2012 | Bristol-Myers Squibb and Pfizer Receive Complete Response Letter From U.S. Food and Drug Administration for Eliquis (Apixaban) |
Mar 1, 2012 | U.S. Food and Drug Administration Extends Action Date for Eliquis (apixaban) by Three Months |
Nov 29, 2011 | FDA Accepts Eliquis (apixaban) New Drug Application for Review for the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation |
Further information
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