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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

DateArticle
Sep 23, 2022Artivion Follows Recommendation to Stop PROACT Xa Clinical Trial
Aug 21, 2014Approval FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism
Mar 18, 2014Approval FDA Approves Eliquis to Reduce Risk of Blood Clots Following Hip Or Knee Replacement Surgery
Jul 11, 2013FDA Accepts Eliquis (apixaban) Supplemental New Drug Application for Review for Prophylaxis of Deep Vein Thrombosis Following Hip Or Knee Replacement Surgery
Dec 28, 2012Approval FDA Approves Eliquis to Reduce the Risk of Stroke, Blood Clots in Patients with Non-Valvular Atrial Fibrillation
Sep 26, 2012FDA 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, 2012Bristol-Myers Squibb and Pfizer Receive Complete Response Letter From U.S. Food and Drug Administration for Eliquis (Apixaban)
Mar  1, 2012U.S. Food and Drug Administration Extends Action Date for Eliquis (apixaban) by Three Months
Nov 29, 2011FDA Accepts Eliquis (apixaban) New Drug Application for Review for the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation

See also

Eliquis (apixaban) Consumer information

Further information

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