Institute of Medicine of Chicago - US Food and Drug Administration FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.

US Food and Drug Administration FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.

29 Jul 2026 12:34 PM | Deborah Hodges (Administrator)

Room-temperature-stable and rapidly reconstituted, this first FDA-licensed product brings new options to emergency and remote settings

The U.S. Food and Drug Administration today licensed Ezplaz Freeze Dried Plasma (FDP), making it 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.

"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, B. Pharm., M.S., 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."