FDA Licenses First Freeze-Dried Plasma Product in the United States

Washington, D.C., July 29, 2026 — The U.S. Food and Drug Administration (FDA) has licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product approved for use in the United States. The milestone is expected to improve access to life-saving plasma transfusions in emergency situations where conventional frozen plasma is unavailable.

According to the FDA, Ezplaz is indicated for transfusion in adult patients who require plasma when other plasma products are not available. The approval provides healthcare professionals with a new option for managing severe bleeding in challenging environments, including combat zones, disaster response operations, rural healthcare facilities, and other remote settings.

Unlike conventional plasma, which must be stored frozen and thawed before administration, Ezplaz can be stored at room temperature and rapidly reconstituted before use. It is also packaged in a durable plastic bag instead of a glass bottle, reducing the risk of breakage during transportation and handling.

The product is derived from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments and is available in Group AB and low-titer Group A plasma to help reduce compatibility risks when a patient's blood type has not yet been determined during emergencies.

FDA officials described the approval as a significant step toward expanding access to plasma in situations where timely treatment can mean the difference between life and death. They noted that the product addresses an important unmet need, particularly for military personnel, emergency responders, and patients in austere environments where traditional hospital infrastructure may not be available.

Ezplaz may be used in adults experiencing severe bleeding, patients requiring massive transfusion, and certain patients receiving warfarin who develop serious bleeding when conventional plasma products are unavailable.

Each Ezplaz kit contains one unit of freeze-dried plasma, a 250 mL bag of sterile water for injection, a sterile fluid transfer set, and a sterile blood transfusion set, allowing rapid preparation for clinical use.

The FDA stated that its review found the benefits of Ezplaz outweigh its risks for the approved indication. The safety profile is consistent with other plasma products currently used for transfusion, although healthcare professionals are advised to follow the approved prescribing information and remain aware of the known risks associated with plasma transfusion.

The biologics license was granted to Vascular Solutions, LLC, a subsidiary of Teleflex.

Relevance to Global Healthcare

The approval marks an important advancement in transfusion medicine and emergency care. Freeze-dried plasma has long been considered a promising innovation because it overcomes many of the logistical challenges associated with frozen plasma, including cold-chain storage and lengthy thawing times.

Although the product is currently licensed for use in the United States, the development may attract interest from healthcare systems worldwide, including countries seeking to strengthen trauma care, military medicine, emergency response, and disaster preparedness.

Source: U.S. Food and Drug Administration (FDA).