Posted by Michael Wonder on 26 Jul 2023
Octapharma's prothrombin complex concentrate, Balfaxar, receives FDA approval for warfarin reversal in urgent surgery & invasive procedures
26 July 2023 - Octapharma USA today announced that Balfaxar (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as Octaplex) has received US FDA approval for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.
The FDA approval is supported by the clinical trial LEX-209, which compared the efficacy and safety of Balfaxar head to head with a control 4F-PCC (Kcentra).
