SILVER SPRING, Md., July 29, 2026
The U.S. Food and Drug Administration (FDA) has licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product approved in the United States for transfusion in adult patients requiring plasma when conventional plasma products are unavailable. The biologics license was granted to Vascular Solutions, LLC, a subsidiary of Teleflex, marking a major advancement in emergency transfusion medicine. Unlike traditional frozen plasma, Ezplaz can be stored at room temperature, rapidly reconstituted, and transported without cold-chain requirements, making it especially valuable for military operations, disaster response, rural healthcare, and other austere environments where immediate access to blood products is limited. FDA officials stated that the approval addresses a significant unmet medical need by expanding treatment options for patients experiencing life-threatening bleeding when conventional plasma supplies cannot be accessed quickly.
Room-Temperature Plasma Enhances Emergency and Military Care
Ezplaz Freeze Dried Plasma is produced from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments and is available in Group AB and low-titer Group A plasma, helping reduce transfusion risks before a patient’s blood type is confirmed. The product offers several operational advantages over conventional frozen plasma, including room-temperature storage, stability during temperature fluctuations, rapid reconstitution, and packaging in durable plastic bags instead of glass bottles to improve transport safety. Each treatment kit includes one unit of freeze-dried plasma, sterile water for injection, a fluid transfer set, and a blood transfusion set, creating a self-contained system designed for rapid deployment. The FDA noted that the product is intended for adults requiring plasma during massive bleeding, trauma, emergency transfusions, warfarin-associated bleeding, combat injuries, disaster response, and remote healthcare settings where frozen plasma is unavailable.
FDA Approval Expands Blood Product Innovation
The FDA emphasized that Ezplaz represents a significant innovation in transfusion medicine while maintaining established standards for safety, purity, and potency. The agency highlighted that freeze-dried plasma was identified as a priority product through collaboration between the U.S. Department of Defense and FDA to accelerate development of therapies addressing life-threatening conditions affecting military personnel. Clinical evaluation demonstrated that the product’s safety profile is consistent with existing plasma products used in transfusion medicine, while offering important logistical advantages for emergency care. According to the FDA, room-temperature stability and rapid preparation could significantly improve access to plasma in combat zones, disaster relief operations, rural hospitals, and emergency medical transport systems where conventional frozen plasma may not be practical.
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Freeze-Dried Plasma Marks Major Advancement in Transfusion Medicine
The FDA’s approval of Ezplaz Freeze Dried Plasma represents a milestone for both emergency medicine and military healthcare by introducing the first FDA-licensed freeze-dried plasma product into the U.S. market. The combination of rapid availability, simplified storage, portability, and compatibility with challenging clinical environments has the potential to improve trauma care and lifesaving transfusion support for critically injured patients. As emergency preparedness and battlefield medicine continue to evolve, the availability of room-temperature plasma could significantly strengthen healthcare providers’ ability to respond quickly during mass casualty events, remote medical missions, and natural disasters while expanding access to advanced transfusion therapies beyond traditional hospital settings.
Source: FDA, press release
