Product Information

• Kogenate FS Package Insert - For Intravenous Use (PDF - 403KB)
• Package Insert - Kogenate FS, Antihemophilic Factor w Vial Adapter (PDF - 316KB)
• Package Insert - Kogenate FS w BIO-SET (PDF - 308KB)

Supporting Documents

• March 18, 2010 Approval Letter - Kogenate FS
  Revised: To request an increase of non-refrigerated storage temperature.
• October 10, 2008 Approval Letter - Kogenate FS
  Revise Indications for Use: To include routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children.
• Final Review Memo - Kogenate FS (PDF - 547KB)
• June 26, 2000 Approval Letter - Kogenate FS
  Manufacturing Change: New product formulation

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 Drug to Prevent Joint Damage in Children with Hemophilia A [ARCHIVED]
  Press Release: 10/10/2008

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