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FDA licenses Ezplaz, the first freeze-dried plasma for use in the U.S.

The new plasma product reconstitutes in about one minute and features specialized packaging to reduce accidental breakage

FILE - The U.S. Food and Drug Administration building is seen behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md., Aug. 2, 2018. (AP Photo/Jacquelyn Martin, File) (Jacquelyn Martin/AP)

ORLANDO, Fla. — The FDA today licensed Ezplaz, the first freeze-dried plasma approved for use in the U.S., a move officials say could speed life-saving transfusions in emergencies when frozen plasma isn’t available.

Ezplaz, designed for adults needing plasma, reconstitutes in about a minute. Packaged to reduce breakage, it’s ideal for disaster response, rural care, and combat settings.

“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, acting director of the FDA’s Center for Biologics Evaluation and Research.

The product is offered in Group AB and low‑titer Group A blood types to lower risk when a patient’s blood type isn’t yet known. Each kit includes the freeze-dried plasma pouch, sterile water, and transfusion sets.

For its approved uses, the FDA says the benefits outweigh the risks, and the safety profile is consistent with other plasma products; providers should review the full prescribing information.

Freeze-dried plasma has been prioritized under a 2017 law that accelerated DoD–FDA collaboration on critical products for military personnel, with related FDA guidance issued in 2019.

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Angel Green

Angel Green, WFTV.com

Angel Green is a Content Creator for WFTV.com.

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