Product Approval Information
Proper Name: Antithrombin (Recombinant)
Tradename: ATryn
Manufacturer: GTC Biotherapeutics, Inc., License # 1794
- Package insert (PDF, 260 KB) - February 6, 2009
Date: February 6, 2009
Indication: For the prevention of peri-operative and peri-partum thromboembolic events, in hereditary antithrombin deficient patients.
February 6, 2009 Approval Letter
FDA News: FDA Approves Orphan Drug ATryn to Treat Rare Clotting Disorder
Summary Basis for Regulatory Action
Approval History, Letters, Reviews, and Related Documents
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