FDA panel gives nod to GTC's antithrombin

19 January 2009

USA-based drug developer GTC biotherapeutics' human antithrombin ATryn has been recommended by the Food and Drug Administration's Blood  Products Advisory Committee for approval in the prevention and treatment  of venous thromboembolism in hereditary antithrombin-deficient patients  undergoing surgery or childbirth.

In September last year, the FDA assigned Priority Review to the Biologic  License Application for ATryn with an action date of February 7. GTC has  licensed the drug to Ovation Pharmaceuticals to develop and market in  the USA.

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