FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.

The U.S. Food and Drug Administration announced the licensure of Ezplaz Freeze Dried Plasma (FDP), the first freeze-dried plasma product licensed in the United States. It is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available, addressing an unmet need in combat zones, disasters, rural settings, and other austere environments.

Ezplaz is a lyophilized plasma product derived from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments. It is available in Group AB and Group A with low-titer anti-B blood types, chosen to reduce the risk of transfusion reactions in emergencies before a patient's blood type is known. Unlike conventional frozen plasma, Ezplaz can be stored at room temperature, remains stable after temperature fluctuations, and is rapidly reconstituted. It is packaged in a plastic bag instead of glass to reduce breakage risk during transport.

The product is indicated for adults requiring plasma when other plasma products are unavailable, including bleeding patients, those needing massive transfusion, or certain patients on warfarin who are bleeding. Each Ezplaz kit is self-contained and includes one unit of freeze-dried plasma in a foil pouch, a 250 mL bag of sterile water for injection, a sterile fluid transfer set, and a sterile blood transfusion set.

FDA officials highlighted that the licensure demonstrates the advancement of innovation alongside rigorous scientific review, expanding treatment options while maintaining safety, purity, and potency standards. Freeze-dried plasma was among the first products identified under Public Law 115-92, which authorized DoD-FDA collaboration to expedite development of products for serious or life-threatening conditions facing military personnel, leading to 2019 FDA guidance for dried plasma products.