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Human thrombin OK’d

This article was originally published in The Gray Sheet

Executive Summary

FDA approves the biologics license application for Evithrom, a protein that helps control bleeding during surgery, Aug. 27. Evithrom, manufactured by Omrix Biopharmaceuticals and marketed by Johnson & Johnson/Ethicon, is the first human thrombin approved since 1954, and will be the only such product on the market, according to FDA. Derived from human plasma from U.S. donors, human thrombin may prevent the immunogenic response some patients have to bovine-derived thrombin. Ethicon will market Evithrom both as a standalone thrombin and in conjunction with the absorbable gel sponge Surgiflo hemostatic matrix with FlexTip...



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