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  • January 7, 2026
  • FDA
  • FDA Approves New 2-Gram Presentation of Fibryga®, Enhancing Convenience and Precision in Treating Acquired Fibrinogen DeficiencyFDA Approves New 2-Gram Presentation of Fibryga®, Enhancing Convenience and Precision in Treating Acquired Fibrinogen Deficiency

FDA Approves New 2-Gram Presentation of Fibryga®, Enhancing Convenience and Precision in Treating Acquired Fibrinogen DeficiencyFDA Approves New 2-Gram Presentation of Fibryga®, Enhancing Convenience and Precision in Treating Acquired Fibrinogen Deficiency

The 2-gram single-dose bottle joins the existing 1-gram version, giving clinicians more options for streamlined dosing and reconstitution in urgent bleeding scenarios
Octapharma USA, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new 2-gram presentation of Fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in patients with acquired fibrinogen deficiency (AFD).

This new kit includes 100 mL of Water for Infusion (WFI) and continues to feature the nextaro® reconstitution device, offering enhanced convenience and flexibility for healthcare providers.

FibrygaThe 2-gram single-dose bottle joins the existing 1-gram version, giving clinicians more options for streamlined dosing and reconstitution in urgent bleeding scenarios. This innovation reflects Octapharma’s ongoing commitment to advancing patient care through insightful product development and clinical excellence in the use of factor concentrates.

“The introduction of the 2-gram Fibryga® kit is a direct response to the needs of clinicians managing critical bleeding,” said Flemming Nielsen, President, Octapharma USA. “By simplifying preparation and expanding dosing flexibility, we’re helping providers act faster and more precisely – when every second counts.”

Fibryga® is the first and only virus-inactivated, human plasma-derived fibrinogen concentrate approved for AFD in the U.S. The product’s lyophilized powder formulation allows for rapid reconstitution at the point of care, offering a more consistent and targeted alternative to cryoprecipitate, which has long been the standard of care despite its limitations.

The expanded product line builds on the success of Fibryga’s 2024 FDA approval for AFD, which was supported by the landmark FIBRES study published in JAMA. The study demonstrated that fibrinogen concentrate is non-inferior to cryoprecipitate in managing bleeding during surgery, with the added benefits of standardized dosing, faster preparation, and reduced risk of viral transmission.

“Octapharma continues to invest in innovations that improve outcomes for patients with serious bleeding complications,” said Huub Kreuwel, Ph.D., Vice President of Medical Affairs,Octapharma USA. “The new 2-gram Fibryga® kit is another step forward in our mission to redefine the standard of care in hemostasis.”
Fibryga® is now approved in the U.S. for fibrinogen supplementation in both congenital and acquired fibrinogen deficiency, and is available in 1-gram and 2-gram kits, each with the nextaro® device for efficient reconstitution.

Other FDA news items can be found here.