FDA clears first freeze-dried plasma for emergency transfusion

Hemorrhage remains the leading cause of preventable death after trauma, and early plasma transfusion is a key component of balanced resuscitation. Conventional plasma requires frozen storage and thawing, limiting its availability outside hospitals. FDA has authorized marketing of Ezplaz, the first freeze-dried plasma product licensed for use in the United States, potentially expanding access to plasma in prehospital, rural, military, and disaster settings.

Ezplaz is indicated for transfusion in adults who require plasma when other plasma products are not available. Potential use cases include patients with severe bleeding, those requiring massive transfusion, and selected patients with warfarin-associated bleeding. It is derived from a single unit of fresh frozen plasma and is available as Group AB and low-titer Group A plasma to reduce the risk of ABO incompatibility when blood type is unknown.

Unlike conventional plasma, Ezplaz is stored at room temperature, tolerates temperature fluctuations, and can be reconstituted in about 1 to 2.5 minutes for transfusion. Each self-contained kit includes the freeze-dried plasma, sterile water, a transfer set, and a blood transfusion set. The product is packaged in a durable plastic bag rather than glass, making it more practical for transport and field use.

For emergency physicians, trauma surgeons, critical care clinicians, emergency medical services, and military medical teams, the approval could improve the ability to initiate plasma transfusion earlier in settings where frozen plasma is impractical or unavailable, including rural hospitals, disaster responses, and combat casualty care. While Ezplaz is intended for situations in which conventional plasma cannot be accessed, its availability may help address longstanding logistical barriers to early hemorrhage control.

FDA noted that the safety profile of Ezplaz is consistent with other plasma products used for transfusion, and clinicians should remain aware of standard transfusion-associated risks and consult the full prescribing information before use.

“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 FDA Center for Biologics Evaluation and Research.

Source: Food and Drug Administration. (2026 July 29). FDA licenses first-ever freeze-dried plasma product in the U.S.