The FDA has licensed Ezplaz Freeze Dried Plasma, the first freeze-dried plasma product approved for use in the U.S.
Ezplaz is indicated for transfusion in adult patients who need plasma when other plasma products are unavailable, including patients with life-threatening bleeding, those requiring massive transfusion and certain patients taking warfarin who are bleeding, according to a July 29 agency news release. Unlike conventional plasma, the product can be stored at room temperature, withstand temperature fluctuations and be rapidly reconstituted.
The FDA said the product’s storage and handling characteristics could expand access to plasma in combat zones, disaster response settings, rural areas and other austere environments where frozen plasma may not be available.
The agency granted the biologics license to Vascular Solutions, a subsidiary of Teleflex. It said the product’s safety profile is consistent with other plasma products used for transfusion and determined that the benefits outweigh the risks for its approved uses.
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