On July 29, 2026, the U.S. Food and Drug Administration licensed Ezplaz Freeze Dried Plasma (FDP), the first freeze-dried plasma product authorized for use in the United States. The FDA determined that, for the uses approved under the license, the benefits of Ezplaz transfusion outweigh the risks. The licensure is presented as an advance in options for plasma transfusion in settings where conventional plasma products may be unavailable.
Ezplaz is indicated for transfusion in adult patients when plasma is required and other plasma products are not available. Specific clinical scenarios cited in the licensure include: patients experiencing bleeding, patients requiring massive transfusion, and certain bleeding patients on warfarin. The product is intended for use in situations where timely access to conventional frozen plasma is limited or impossible.
Ezplaz is produced by lyophilizing a single unit of fresh frozen plasma collected from FDA-licensed blood establishments. The product is provided in two blood-group presentations: Group AB and Group A with low-titer anti-B. These group selections are intended to mitigate the risk of transfusing plasma before a recipient's blood type is known in emergency settings.
Each Ezplaz kit is a complete, self-contained package that includes:
These components are provided to enable rapid reconstitution and administration in the field or in other nontraditional care environments.
A central feature of Ezplaz is that it can be stored at room temperature and remains stable after exposure to temperature fluctuations. Unlike conventional plasma products that require frozen storage and thawing before use, Ezplaz is rapidly reconstituted with the included sterile water for injection.
The product is packaged in a plastic bag rather than a glass bottle, which reduces the risk of breakage during handling and transport. The FDA noted that these attributes—room-temperature stability, tolerance of temperature fluctuations, rapid reconstitution, and breakage-resistant packaging—are expected to make Ezplaz compatible with austere environments, including combat zones, remote areas, and disaster response settings where infrastructure for frozen plasma storage may be lacking.
The FDA stated that the safety profile of Ezplaz is consistent with other plasma products used for transfusion. For licensed uses, the agency found the benefits of transfusion with Ezplaz outweigh the associated risks. As with all plasma products, there are transfusion-related risks that patients and healthcare providers should be aware of. The FDA advised healthcare providers to review the full prescribing information prior to using Ezplaz.
No novel safety signals or specific adverse event rates were detailed in the announcement; those details are contained in the product labeling and full prescribing information referenced by the FDA.
Freeze-dried plasma was identified as a priority product under Public Law 115-92 (enacted December 2017), which authorized collaboration between the Department of Defense and the FDA to expedite development and review of medical products addressing serious or life-threatening conditions affecting American military personnel. In support of product development, the FDA issued guidance in 2019 titled "Considerations for the Development of Dried Plasma Products Intended for Transfusion" to assist manufacturers developing dried plasma products for transfusion.
The licensure of Ezplaz is presented by the FDA as an example of innovation proceeding alongside rigorous scientific review to expand treatment options while maintaining standards for safety, purity, and potency.
The biologics license for Ezplaz was granted to Vascular Solutions, LLC, a subsidiary of Teleflex. The FDA announcement identifies Vascular Solutions as the license holder; no additional distribution, availability timelines, or commercial rollout details were provided in the press release.
For media inquiries, the FDA provided a media contact pathway and a consumer information line (888-INFO-FDA). The press release also points readers to FDA resources and the 2019 guidance document for manufacturers developing dried plasma products.
Content in the FDA news release is current as of July 29, 2026. Additional prescribing information and product labeling are the primary sources for detailed clinical and safety data; healthcare providers should consult those materials prior to use.