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: Sorafenib
Trade Name: Nexavar
Date Designated: 04/20/2006
Orphan Designation: Treatment of hepatocellular carcinoma
Orphan Designation Status: Designated/Approved
Bayer Pharmaceuticals Corporation
400 Morgan Lane
West Haven, Connecticut 06516
United States

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

Marketing approved:

1 Generic Name: Sorafenib
Trade Name: Nexavar
Marketing Approval Date: 11/16/2007
Approved Labeled Indication: Treatment of unresectable hepatocellular carcinoma
Exclusivity End Date: 11/16/2014 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-