Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: Antihemophilic factor (recombinant)
Trade Name: Kogenate
Date Designated: 09/25/1989
Orphan Designation: Prophylaxis and treatment of bleeding in individuals with hemophilia A or for prophylaxis when surgery is required in individuals with hemophilia A.
Orphan Designation Status: Designated/Approved
Bayer Corporation
1884 Miles Avenue
Elkhart, Indiana 46515
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Antihemophilic factor (recombinant)
Trade Name: Kogenate
Marketing Approval Date: 02/25/1993
Approved Labeled Indication: Treatment and prophylaxis of bleeding in patients with hemophilia A (not von Willebrand's disease)
Exclusivity End Date: 02/25/2000 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-