FDA Issues Its First Freeze-Dried Plasma License
On July 29, 2026, the FDA announced that it had licensed EZPLAZ FDP, the first freeze-dried (lyophilized) plasma product to be licensed in the United States. The license was issued to Vascular Solutions LLC, a subsidiary of Teleflex Incorporated.
EZPLAZ FDP is considered a biologic and is derived from a single unit of donor human fresh frozen plasma that is reconstituted before intravenous or intraosseous transfusion. Per the FDA announcement, it is indicated for adults requiring plasma transfusion when other plasma products are not available. It may be administered to patients with blood group AB or A, including patients who are bleeding, patients requiring massive transfusion, and bleeding patients on warfarin.
According to the FDA, conventional plasma products must be kept frozen and thawed before use where EZPLAZ FDP can be stored in its plastic bag at standard room temperature for up to 12 months. The FDA announcement notes that this storage profile is relevant to settings where frozen plasma is difficult to maintain, including emergency, disaster, combat, and remote care.
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