Product Approval Information
Proper Name: Antithrombin (Recombinant)
Tradename: ATryn
Manufacturer: GTC Biotherapeutics, Inc., License # 1794
STN:125284/0
Approval Date: February 6, 2009
Approval information/letter/labeling
Memorandum/Reviews
- 483 Response Review Memo
- 483 Response Review Memo - PLI
- Approval of Biologics License Application (PDF- 311 KB)
- Acknowledgment Letter
- Acknowledgment Letter
- Bioresearch Monitoring Final Review Memo
- BLA GTC Biotherapeutics (PDF- 270 KB)
- BLA Mid-Cycle Review Memo
- Categorical exclusion under 21 CFR § 25.31(c)
- Clinical Pharmacology Review (PDF-196 KB)
- Environmental Assessment (PDF 132 KB)
- FDA-483 Review
- Filing Letter
- Final Review Memo (1/21/2009)
- Final Review Memorandum (1/16/2009)
- Finding of No Significant Impact (12/29/2008)
- GTC Biotherapeutics (PDF-370 KB)
- Mid-Cycle Review of GTC’s BLA
- Mid Cycle Review Memo (PDF-210 KB)
- Mid-Cycle Meeting Minutes
- Recommendation to waive a pre-licensing inspection
- Recommendation to Grant GTC Biotherapeutics Request (PDF-35 KB)
- Re-evaluation of proposed proprietary name ATryn
- Review for Pharmacovigilance Planning
- Review Memo
- Review of GTC’s Biological License Application (PDF-57 KB)
- Review of proposed proprietary name ATryn
- Statistical Review and Evaluation
- Status of Bioresearch Monitoring Inspections
- Test Results for Residual Moisture
Administrative Documents
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