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Bevyxxa Approval History

  • FDA approved: Yes (First approved June 23rd, 2017)
  • Brand name: Bevyxxa
  • Generic name: betrixaban
  • Dosage form: Capsules
  • Company: Portola Pharmaceuticals, Inc.
  • Treatment for: Prevention of Venous Thromboembolism

Bevyxxa (betrixaban) is an oral, once-daily Factor Xa inhibitor anticoagulant for the extended-duration prophylaxis of venous thromboembolism (VTE) in at-risk adult patients hospitalized for an acute medical illness.

Development History and FDA Approval Process for Bevyxxa

Jun 23, 2017Approval FDA Approves Bevyxxa (betrixaban) for Hospital and Extended Duration Prevention of Venous Thromboembolism (VTE) in Acutely Ill Medical Patients
Dec 23, 2016Portola Pharmaceuticals Announces FDA Accepts NDA for Priority Review for Oral, Factor Xa Inhibitor Anticoagulant Betrixaban
Oct 25, 2016Portola Pharmaceuticals Submits NDA to U.S. FDA for Betrixaban for Extended Duration Prophylaxis of Venous Thromboembolism in Acute Medically Ill Patients
May 27, 2016Portola Pharmaceuticals Announces Full Results of Phase 3 APEX Study of Betrixaban
Mar 15, 2010Portola Pharmaceuticals and Merck Announce that Phase 2 Study Showed Investigational Factor Xa Inhibitor, Betrixaban, Reduced Incidence of Bleeding Compared to Warfarin in Patients with Atrial Fibrillation

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