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: denosumab
Trade Name: Xgeva
Date Designated: 12/20/2010
Orphan Designation: Treatment of patients with giant cell tumor of bone
Orphan Designation Status: Designated/Approved
Amgen, Inc.
One Amgen Center Drive
Thousand Oaks, California 91320
United States

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

Marketing approved:

1 Generic Name: denosumab
Trade Name: Xgeva
Marketing Approval Date: 06/13/2013
Approved Labeled Indication: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Exclusivity End Date: 06/13/2020 
Exclusivity Protected Indication* :  Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-