Teleflex IncorporatedFDA approval of EZPLAZ, the first licensed freeze-dried plasma product, is a regulatory milestone for Teleflex.

Teleflex Incorporated announced that the U.S. FDA has approved its Biologics License Application for EZPLAZ Freeze Dried Plasma, making it the first FDA-licensed freeze-dried plasma product and Teleflex's first biologics license for a blood component. EZPLAZ is indicated for transfusion in adults with bleeding-related conditions requiring replacement of plasma coagulation factors, including uncontrolled hemorrhage, when plasma is needed and other plasma products are not available. Unlike current Emergency Use Authorization products packaged in glass bottles, EZPLAZ uses a patented flexible plastic bag technology designed for easier transport and storage in critical settings such as ambulances, hospitals, and battlefields. The Defense Health Agency partnered with Teleflex through its Warfighter Protection and Acute Care program to develop shelf-stable blood products for frontline medical teams. Teleflex shares closed Wednesday at $134.65, up 0.34%, and rose 1.75% in pre-market trading to $137.00.
Teleflex IncorporatedFDA approval of EZPLAZ, the first licensed freeze-dried plasma product, is a regulatory milestone for Teleflex.