Drug & Regulatory FDA Press Releases

FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.

FDA approvalfreeze-dried plasmaEzplaztransfusion

Ezplaz Freeze Dried Plasma is the first licensed lyophilized plasma product in the United States, providing a shelf life and storage advantages over traditional fresh frozen plasma, which requires continuous cold-chain storage. The product is intended for adult patients needing plasma transfusion when other plasma products are not available, positioning it as a critical contingency option in trauma centers, rural hospitals, and battlefield settings. Freeze-dried plasma can be reconstituted rapidly with sterile water, shortening preparation time and easing portability. This regulatory milestone may open the door for broader adoption of freeze-dried blood products and could prompt further innovation in transfusion logistics. Watch for subsequent studies or expansions to pediatric use and wider clinical indications.

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