REGULATORY UPDATE: FDA Licenses First Freeze-Dried Plasma Product

The Food and Drug Administration licensed Ezplaz Freeze Dried Plasma (FDP), the first freeze-dried plasma product approved 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. This includes bleeding patients, patients needing massive transfusion, and certain patients experiencing bleeding who are being treated with warfarin. FDA has determined that the benefits of transfusion outweigh the risks for approved uses, and the safety profile is consistent with other plasma products used for transfusion.

Unlike conventional plasma, which must be stored frozen and thawed before use, Ezplaz can be stored at room temperature, remains stable through temperature fluctuations and is rapidly reconstituted. It is packaged in a plastic bag rather than a glass bottle to reduce the risk of breakage during handling and transport. The agency expects these features to make the product suitable for austere settings, including combat zones, remote areas and disaster response.

Ezplaz is derived from a single unit of fresh frozen plasma collected from FDA-licensed blood establishments. It is available in Group AB and Group A with low-titer anti-B. These blood types were selected to reduce risk when transfused in emergencies before a patient's blood type is known. Each kit is self-contained and includes one freeze-dried plasma unit, sterile water for injection, a fluid transfer set and a blood transfusion set.

FDA clarified that the biologics license was granted to Vascular Solutions LLC, a subsidiary of Teleflex, and that the company was required to develop their own Circular of Information, which will be distributed with the product; therefore inclusion in the AABB Circular of Information is not required.