Ezplaz Freeze-Dried Plasma Receives First Ever FDA License in the US

The US Food and Drug Administration (FDA) has licensed Ezplaz Freeze Dried Plasma, the first freeze-dried plasma product licensed for use in the United States. Ezplaz is indicated for transfusion in adult patients who need plasma and for whom other plasma products are not available. The Agency announced the licensure July 29, 2026, granting the biologics license to Vascular Solutions, LLC, a subsidiary of Teleflex.

Frozen plasma has long carried logistical constraints unsuited to combat, rural, or disaster settings: cold-chain storage, a thaw cycle before infusion, and fragile glass packaging all limit its use outside conventional hospital infrastructure. A room-temperature-stable, rapidly reconstituted plasma product removes those constraints for patients with life-threatening bleeding who cannot reach a blood bank in time. Ezplaz's licensure gives clinicians in austere environments a transfusion option previously unavailable in the US market.

“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,” Anne Eder, MD, PhD, Director of the Office of Blood Research and Review (CBER), said in a statement.

Ezplaz Freeze-Dried Plasma Indication and Product Design

Ezplaz is manufactured from a single unit of fresh frozen plasma collected at FDA-licensed blood establishments, then lyophilized into a shelf-stable powder. The product is available in blood group AB and blood group A with low-titer anti-B, a selection intended to limit risk when transfusion occurs before a patient's blood type is confirmed. Each kit ships as a complete, self-contained unit: one foil-sealed pouch of freeze-dried plasma, a 250 mL bag of sterile water for injection, a sterile fluid transfer set, and a sterile blood transfusion set.

The license covers transfusion in adults who require plasma and for whom other plasma products are not available, including patients with active bleeding, patients requiring massive transfusion, and certain bleeding patients on warfarin. Unlike conventional frozen plasma, which requires cold-chain storage and a thaw cycle before administration, Ezplaz can be stored at room temperature, tolerates temperature fluctuation, and reconstitutes rapidly at the point of care. Its plastic-bag packaging, in place of a glass bottle, is designed to reduce breakage risk during transport in field or disaster settings.

The biologics license was granted to Vascular Solutions, LLC, a subsidiary of Teleflex. Development proceeded under the authority of Public Law 115-92, enacted in December 2017, which established a Department of War-FDA collaboration to expedite review of products addressing serious or life-threatening conditions facing military personnel. The FDA issued guidance in 2019 on the development of dried plasma products intended for transfusion to support manufacturers pursuing this pathway.

Ezplaz Safety Profile and FDA Regulatory Pathway

The FDA has determined the benefits of Ezplaz transfusion outweigh the risks for its approved uses, and characterizes its safety profile as consistent with other plasma products currently used for transfusion. No new safety signals were noted in the agency's announcement. Because Ezplaz is derived from a single donor unit and undergoes lyophilization rather than the standard fresh-freeze process, the agency's review focused on demonstrating the finished product meets established standards for safety, purity, and potency despite the altered manufacturing pathway.

Providers are directed to review the full prescribing information before administration, particularly given the product's intended use in emergency settings where blood typing may not yet be confirmed. Selection of AB and low-titer anti-B group A units was itself a risk-mitigation measure built into the product's design.

“Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma when conventional frozen plasma is unavailable,” said Karim Mikhail, BPharm, MS, Acting Director of the Center for Biologics Evaluation and Research (CBER). “This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure.”

Freeze-dried plasma was among the first product categories identified for expedited development under the DoD-FDA collaboration authorized by Public Law 115-92 in December 2017. Ezplaz is now the first product from this pathway to reach US licensure, positioning it as a reference point for other dried plasma products still in development.

References

1. U.S. Food and Drug Administration. FDA licenses first-ever freeze-dried plasma product in the U.S. Published July 29, 2026. Accessed July 29, 2026. https://www.fda.gov/news-events/press-announcements/fda-licenses-first-ever-freeze-dried-plasma-product-us

2. U.S. Food and Drug Administration. Considerations for the development of dried plasma products intended for transfusion. Guidance document. Published 2019. Accessed July 29, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-development-dried-plasma-products-intended-transfusion