Teleflex Announces FDA BLA Approval of EZPLAZ™ Freeze Dried Plasma
First and only FDA-Approved Freeze Dried Plasma Product
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced it has received Biologics License Application (BLA) approval for EZPLAZ™ Freeze Dried Plasma (FDP) from the U.S. Food and Drug Administration (FDA). EZPLAZ™ FDP is approved for transfusion in adults with bleeding-related conditions requiring replacement of plasma coagulation factors, including uncontrolled bleeding (hemorrhage), when plasma is required and other plasma products are not available. This landmark approval is the first freeze dried plasma licensed by the FDA, and the first biologics license for a blood component for Teleflex.
“EZPLAZ™ FDP can potentially enable the transfusion of plasma in situations where it is critically needed, including air and road ambulances, in the hospital, and on the battlefield,” said Jake Newman, President and General Manager, Global Vascular and Emergency Medicine at Teleflex. “While current Emergency Use Authorization FDP products use glass bottles as containers, EZPLAZ™ FDP utilizes a patented flexible plastic bag technology. The BLA approval of EZPLAZ™ FDP is a critical milestone for our customers and for Teleflex, as we continue to expand our emergency medicine portfolio.”
