Omrix gets FDA approval for Evicel in liver surgery

By Elaine Rigoli

Tampa, Fla., July 10 - Omrix Biopharmaceuticals, Inc. has been granted marketing clearance from the Food and Drug Administration for its second-generation fibrin sealant, Evicel, to control bleeding (hemostasis) during liver surgery.

The company said Evicel differs from the first-generation fibrin sealant, Crosseal, in that Evicel does not contain a stabilizer, and therefore will not have the neurosurgical contraindication required of Crosseal.

Also announced Monday, the company said it has submitted a Prior Approval Supplement to the FDA containing the results of a prospective, randomized, multi-center phase 3 controlled study comparing the hemostatic efficacy of Evicel to standard-of-care in peripheral vascular surgery in 150 patients.

The company said it submitted this data in order to expand the indication of Evicel to include vascular surgery.

Omrix is a commercial-stage biopharmaceutical company located in New York.

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