Overview
- The FDA granted a biologics license for Ezplaz Freeze Dried Plasma to Vascular Solutions on July 29, 2026 for use in adults who need plasma when other plasma products are unavailable.
- Ezplaz is supplied as a single-unit, self-contained kit that contains lyophilized plasma sealed in a foil pouch, a 250 mL sterile water bag, a sterile fluid transfer set, and a sterile blood transfusion set.
- The product is available in Group AB and Group A with low-titer anti-B to reduce the risk of ABO incompatibility when a patient’s blood type is unknown in emergency transfusions.
- The FDA said Ezplaz’s safety profile is consistent with other plasma products and that its room-temperature stability, tolerance of temperature fluctuations, rapid reconstitution, and plastic packaging make it easier to store and transport in austere environments.
- Freeze-dried plasma was a DoD–FDA priority under 2017 Public Law 115-92 and 2019 FDA guidance, and the new licensure formalizes a long-standing military and disaster-response development goal as a marketed clinical option.