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Prolia FDA Approval History

FDA Approved: Yes (First approved June 1, 2010)
Brand name: Prolia
Generic name: denosumab
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Osteoporosis

Prolia is a RANK ligand (RANKL) inhibitor indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, for the treatment of bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy, as a treatment to increase bone mass in men with osteoporosis at high risk for fracture, and for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture.

Development timeline for Prolia

May 21, 2018Approval FDA Approves Prolia (denosumab) for Glucocorticoid-Induced Osteoporosis
Sep 21, 2012Approval FDA Approves New Indication For Prolia (Denosumab) For The Treatment Of Bone Loss In Men With Osteoporosis At High Risk For Fracture
Sep 19, 2011Approval FDA Approves New Indications for Prolia (denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
Jun  1, 2010Approval FDA Approves Amgen's Prolia (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture
May 17, 2010Amgen Submits Denosumab Biologics License Application to FDA for the Reduction of Skeletal Related Events in Cancer Patients
Oct 21, 2009Amgen Provides Update on Status of Prolia (denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration (FDA)
Aug 14, 2009Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
Feb 18, 2009FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab
Dec 22, 2008Amgen Submits Biologics License Application for FDA Approval of Denosumab in Women With Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation for Either Prostate or Breast Cancer

Further information

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