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Omrix/Ethicon hemostat advances toward goal

This article was originally published in The Gray Sheet

Executive Summary

Fibrin sealant Evicel, manufactured by Omrix Biopharmaceuticals and marketed by Johnson & Johnson/Ethicon, gains FDA approval for expanded indication May 9. FDA originally licensed the product's predecessor, Crosseal, in 2003 to help control bleeding during liver surgery; the new supplemental biologics license application allows use of the slightly reformulated Evicel in vascular surgery as well. Meanwhile, on March 8, Omrix filed for approval of its end goal for Evicel: an indication for general hemostasis in surgery, which would sanction use in any surgical procedure where bleeding is a problem. An FDA decision is expected by Jan. 8, 2008, the firm says. Evicel, a liquid, competes primarily with Baxter's Tisseel, which is sold in powdered form...
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