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ATryn Approval History

  • FDA approved: Yes (First approved February 6th, 2009)
  • Brand name: ATryn
  • Generic name: Antithrombin (Recombinant)
  • Company: GTC Biotherapeutics, Inc.
  • Treatment for: Antithrombin III Deficiency

ATryn (Antithrombin (Recombinant)) is a recombinant form of human antithrombin for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.

Development History and FDA Approval Process for ATryn

Feb  6, 2009Approval ATryn (Antithrombin [Recombinant]) Approved by the FDA
Jan 12, 2009FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn (antithrombin [Recombinant])
Oct  6, 2008ATryn (antithrombin alfa) BLA Filing Accepted by FDA
Aug  7, 2008GTC Biotherapeutics Completes BLA Submission For ATryn

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