EZPLAZ Freeze Dried Plasma (FDP)
- Indication
- plasma coagulation factors, including uncontrolled bleeding (hemorrhage)
- Stage
- phase6
- Event
- Approved
- Details
July 29, 2026: Teleflex Incorporated (NYSE: TFX) announced the FDA approved its Biologics License Application (BLA) for EZPLAZ™ Freeze Dried Plasma (FDP). EZPLAZ 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. Teleflex states this is the first FDA-licensed freeze dried plasma product and its first biologics license for a blood component.
The product is supplied as a freeze-dried unit of plasma with components for transfusion, including sterile water for injection for reconstitution; it is stored at 2–25°C, has a 12-month shelf life, and can be reconstituted in about 1–2.5 minutes. Teleflex also notes a longstanding development collaboration with the Defense Health Agency via a CRADA initiated in April 2014 (through its subsidiary Vascular Solutions LLC) aimed at developing an FDA-approved, commercially available freeze dried plasma product.
- Source
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