US FDA approves first freeze-dried plasma product for use
TFX•Potential use in emergencies
The FDA said the product could improve access to plasma for patients with life-threatening bleeding in combat zones, disaster-response operations and rural areas with limited hospital infrastructure.
Ezplaz is derived from a single unit of fresh frozen plasma collected at FDA-licensed blood establishments and is available in Group AB and Group A low-titer anti-B blood types for emergency use before a patient's blood type is known.
Supply backdrop and product details
The approval comes as the American Red Cross, one of the largest U.S. suppliers of blood products, grapples with a national blood supply crisis, only the second in its history.
The organization said on Monday that donations have fallen to a four-year summer low, leaving it with less than a one-day national supply of O positive blood and forcing limits on shipments to some hospitals.
Unlike conventional plasma, which must be stored frozen and thawed before use, Ezplaz can be stored at room temperature and rapidly reconstituted.
The product is packaged in a plastic bag rather than a glass bottle, making it easier to transport and less vulnerable to breakage.
FDA approves first freeze-dried plasma product
The U.S. Food and Drug Administration on Wednesday approved the first freeze-dried plasma product for use in the country, providing an option for patients when conventional plasma is unavailable.
The agency granted a biologics license to Vascular Solutions — a subsidiary of Teleflex TFX.N — for Ezplaz Freeze Dried Plasma, which is indicated for adult patients who require plasma transfusions when other plasma products are unavailable.
