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ATryn Approval History

FDA Approved: Yes (First approved February 6, 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

DateArticle
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

Further information

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