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Betrixaban Approval Status

  • FDA approved: No
  • Generic name: betrixaban
  • Company: Portola Pharmaceuticals Inc.
  • Treatment for: Venous Thromboembolism

Betrixaban is an oral, once-daily Factor Xa inhibitor anticoagulant in development for the extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.

Development Status and FDA Approval Process for betrixaban

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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