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