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Coagulation
ATryn® (Antithrombin [Recombinant]) Approved by the FDA
February 28th, 2009
GTC Biotherapeutics ("GTC", NASDAQ: GTCB) and OVATION Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved ATryn® (Antithrombin [Recombinant]) for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients. ATryn is the first ever transgenically produced therapeutic protein and the first recombinant antithrombin approved in the U.S. Along with the approval of ATryn, the FDA's Center for Veterinary Medicine also approved GTC's New Animal Drug Application, the first of its kind to regulate...
Source: Law & Health Weekly (2009-02-28)
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