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Prolia Approval History

  • FDA approved: Yes (First approved June 1st, 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, bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy, and to increase bone mass in men with osteoporosis at high risk for fracture.

Development History and FDA Approval Process for Prolia

DateArticle
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

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