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
| Date | Article |
|---|---|
| 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 |
Further information
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