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JULY 27, 2023

FDA Approves Balfaxar for Warfarin Reversal

By PPN Staff

The FDA approved prothrombin complex concentrate, human-lans (Balfaxar, Octapharma) to reverse acquired coagulation factor deficiency by vitamin K antagonists such as warfarin in adults who need urgent surgery and invasive procedures.


The drug is a nonactivated four-factor prothrombin complex concentrate (4F-PCC) containing several vitamin K–dependent factors, as well as antithrombotic proteins C and S, that replenish levels of clotting factors. Its approval was based on data