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: 09/11/2013
Orphan Designation: Treatment of hypercalcemia in malignancy
Orphan Designation Status: Designated/Approved
Amgen, Inc.
One Amgen Center Drive
MS 17-2-C
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: 12/05/2014
Approved Labeled Indication: To treat hypercalcemia of malignancy refractory to biphosphonate therapy.
Exclusivity End Date: 12/05/2021 
Exclusivity Protected Indication* :  To treat hypercalcemia of malignancy refractory to biphosphonate therapy.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-