Octapharma’s Acquired Coagulation Factor Deficiency Medication Receives FDA Approval

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Balfaxar indicated for restoration of blood coagulation.

Octapharma, a human protein product manufacturer, has announced the FDA approval of Balfaxar, a treatment for acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. According to the company, the medication works to replenish deficient clotting factors due to warfarin therapy, ultimately restoring blood coagulation.


“The FDA approval of Balfaxar® establishes a new therapy for medical providers when their patients need a 4F-PCC product,” said Flemming Nielsen, President, Octapharma USA, in a company press release. "Octapharma is committed to providing patients with lifesaving and life-enhancing therapies for critical care medicine. We are confident Balfaxar® will be a welcomed treatment for physicians who need to quickly restore patients’ coagulation.”

Reference: Octapharma's Prothrombin Complex Concentrate, Balfaxar®, Receives FDA Approval For Warfarin Reversal in Urgent Surgery & Invasive Procedures. Octapharma USA. July 26, 2023. Accessed July 27, 2023. https://www.octapharmausa.com/news/press-release/2023/octapharmas-prothrombin-complex-concentrate-balfaxar-receives-fda-approval-for-warfarin-reversal-in-urgent-surgery-invasive-procedures