The U.S. Food and Drug Administration announced on July 29, 2026, that it had licensed Ezplaz Freeze Dried Plasma (FDP), the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available.
The FDA said the product may provide faster access to plasma for patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments when conventional frozen plasma is unavailable. “This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure,” said Karim Mikhail, B. Pharm., M.S., Acting Director of the Center for Biologics Evaluation and Research.
Product characteristics and approved use
Ezplaz is a freeze-dried, or 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. The FDA said these blood types were chosen to mitigate the risk of transfusing plasma in emergencies before a patient’s blood type is determined.
Unlike conventional plasma products, which must be stored frozen and thawed before use, Ezplaz can be stored at room temperature, remains stable after exposure to temperature fluctuations, and can be rapidly reconstituted. It is packaged in a plastic bag rather than a glass bottle, reducing the risk of breakage during handling and transport. The FDA expects these features to support use in combat zones, remote areas, and disaster response settings.
The product is indicated for adult transfusion when plasma is required and other plasma products are unavailable. The FDA identified bleeding patients, patients needing massive transfusion, and certain patients on warfarin who are bleeding as examples of approved use. Each kit contains one unit of freeze-dried plasma sealed in an outer foil pouch, one 250 mL bag of sterile water for injection, one sterile fluid transfer set, and one sterile blood transfusion set.
For uses covered by the license, the FDA found that the benefits of Ezplaz transfusion outweigh the risks. Its safety profile is consistent with other plasma products used for transfusion, while patients and healthcare providers should remain aware of risks associated with transfusion and review the full prescribing information before use. “This licensure demonstrates that innovation and rigorous scientific review can advance together, expanding treatment options and novel blood components while maintaining FDA’s standards for safety, purity, and potency,” said Anne Eder, M.D., Ph.D., Director of the Office of Blood Research and Review.
Freeze-dried plasma was among the first products identified under Public Law 115-92, enacted in December 2017. The law authorized the DoD, now DoW, and FDA collaboration to assist in expediting development and review of products for serious or life-threatening conditions facing American military personnel. The FDA issued guidance in 2019 to assist manufacturers developing dried plasma products for transfusion. The biologics license was granted to Vascular Solutions, LLC, a subsidiary of Teleflex.