Search Orphan Drug Designations and Approvals

Marketing approved:
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
Sponsor:	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.

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 Jan. 1, 2013, to the present.