Hemostatic efficacy was assessed and 61.5 achieved a rating of good or. The sponsor address listed is the last reported by the sponsor to OOPD. One patient received andexanet alfa for hemoperitoneum bleed reversal indication. infective dosing based on indication for use and renal function. Continued approval for this indication may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients. Andexanet alfa (Andexxa) Indicated for patients treated with. Andexxa was approved under the FDAs Accelerated Approval pathway. 121 Seaport Boulevard Boston, Massachusetts 02210 United States The following table provides supplementary information on the manufacturer and approved indication(s) for each medicine that received first-time market authorization by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2018. Coagulation factor Xa (recombinant), inactivated-zhzoįor reversing the anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgeryĪlexion Pharmaceuticals, Inc.

Andexxa indication