FDA approves sterile blood-plasma product
SILVER SPRING, Md. — The Food and Drug Administraiton has approved a treatment for replacing clotting proteins in the blood for conditions in which patients have too little of them.
The FDA announced the approval of Octapharma's Octaplas, a sterile, frozen solution of pooled human plasma from multiple donors that has been treated with a solvent detergent process.
"For patients suffering with clotting disorders, this product provides a viable alternative to single-donor fresh-frozen plasma and provides a reduced risk of certain viral transmissions," FDA Center for Biologics Evaluation and Research director Karen Midthun said.