STN: BL 125264
Proper Name: Antihemophilic Factor (Recombinant), Plasma/Albumin Free
Manufacturer: Wyeth Pharmaceuticals, Inc, License #0003
- For control and prevention of bleeding episodes and for perioperative management in adults and children with hemophilia A
October 17, 2014 Approval Letter - XYNTHA
To include expansion of the indication for Xyntha® to include all pediatric age groups.
October 14, 2014 Summary Basis for Regulatory Action - XYNTHA(PDF - 583KB) April 12, 2012 Approval Letter - XYNTHA
To demonstrate the safety and efficacy of Xyntha for surgical prophylaxis in patients with hemophilia A.
February 21, 2008 Approval Letter - XYNTHA March 7, 2008 Corrected Approval Letter - XYNTHA Approval History, Letters, Reviews and Related Documents - XYNTHA[ARCHIVED]
FDA Online Label Repository
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FDA Licenses New Hemophilia Treatment[ARCHIVED]
Press Release - February 21, 2008