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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
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
FDA Licenses New Hemophilia Treatment[ARCHIVED]
Press Release - February 21, 2008
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
10903 New Hampshire Avenue
Building 71 Room 3103Silver Spring, MD 20993-0002