Product Approval Information
Proper Name: Antihemophilic Factor (Recombinant), Plasma/Albumin Free
Tradename: XYNTHA
Manufacturer: Wyeth Pharmaceuticals, Inc, License #0003
Package Insert (PDF - 313 KB) - Approved: February 21, 2008
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Date: February 21, 2008
Indication: For control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A
March 7, 2008 Corrected Approval Letter
February 21, 2008 Approval Letter
FDA Licenses New Hemophilia Treatment - February 21, 2008
Approval History, Letters, Reviews, and Related Documents