Thrombosis
FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn
Published in Blood Weekly, January 29th, 2009
GTC Biotherapeutics ("GTC", NASDAQ: GTCB) and OVATION Pharmaceuticals, Inc. announced that the Blood Products Advisory Committee of the U.S. Food and Drug Administration (FDA) voted that ATryn is safe and efficacious for the prevention and treatment of venous thromboembolism in hereditary antithrombin deficient patients undergoing surgery or childbirth procedures. The FDA considers the recommendations of its Advisory Committees when making its determinations. If approved, ATryn will be the first recombinant human antithrombin available in the U.S.
"We are very pleased with the Advisory Committee's recommendation in support of the safety and efficacy of ATryn," said...
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Source: Blood Weekly (2009-01-29)
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