denosumab injection
for subcutaneous use Initial U.S. Approval: 2010

denosumab injection is a RANK ligand (RANKL) inhibitor indicated for: • Prevention of skeletal-related events in patients with bone metastases from solid tumors • 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.

Facts about denosumab injection

Approval Date: 1970
Proprietary Name: On Request
Active Ingredient(s): denosumab injection
Dosage Forms And Strengths: 120 mg/1.7 mL (70 mg/mL) single-use vial
Manufacturer: Amgen Inc.
Medicine Approved By: – European Medical Agency (EMA), Food and Drug Administration (FDA), Health Canada, Therapeutic Goods Administration (TGA), Medsafe (NZ)
Summary of FDA approved use on approval date: Click Here
(see Drugs@FDA for complete indication)

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