Product Information

• Package Insert - XYNTHA (PDF - 373KB)

Supporting Documents

• 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

Related Information

• 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

Contact FDA