Product Approval Information
Proper Name: Antihemophilic Factor (Recombinant), Plasma/Albumin Free
Tradename: XYNTHA
Manufacturer: Wyeth Pharmaceuticals, Inc, License #0003
STN: 125264/0
Approval Date: February 21, 2008
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Approval information/letter/labeling
Memorandum/Reviews
- Chairperson's Summary of Approval
- Final Review Memo: Mid-Cycle Review
- Clinical Pharmacology Review (2/7/2008)
- Clinical Pharmacology Review (9/19/2007)
- Review of CMC Information
- Mid-cycle Review of CMC Information
- Mid Cycle Review Memo (PDF - 598 KB)
- Pharmacology/Toxicology Review Memorandum (9/26/2007)
- Pharmacology/Toxicology Review Memorandum (6/5/2007)
- 1/30/2008 Review
- Summary of Bioresearch Monitoring Inspections
- Statistical Review & Evaluation
- DMPQ Final Memo
- DMPQ Filing Memo
- Filing Memo
- Filing of Wyeth's BLA for Morocotocog Alfa (AF-CC)
- First Committee Meeting Summary
- Mid-Cycle Meeting Memo
Administrative Documents
- Officer/Employee List
- Licensing Action Recommendation (PDF - 184 KB)
- Filing Meeting Summary
- 1/11/2008 Email
- 9/18/2007 Email
- 8/2/2007 Email
- 6/21/2007 Email
- 6/6/2007 Email
- 6/5/2007 Email
- Recommendation to Waive Pre-Approval Inspection
- Request to waive STN 125264 from referral to Blood Products Advisory Committee
Correspondence