Bone Metastases From Solid Tumors

• FDA approval · 2025-12-19
  FDA Approved: BONCRESA — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved BONCRESA (denosumab-mobz) from Amneal Pharmaceuticals LLC under an Original Application. It is indicated for conditions tre…

• FDA approval · 2025-10-29
  FDA Approved: WYOST — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for WYOST (denosumab) submitted by Sandoz Inc, expanding the product's indications.

• FDA approval · 2025-10-29
  FDA Approved: STOBOCLO — Original Application (CELLTRION USA, Inc.)

  FDA approved STOBOCLO (denosumab-BMWO) from Celltrion USA as an original application; a denosumab biosimilar with indications including oste…

• FDA approval · 2025-10-29
  FDA Approved: BILPREVDA — Original Application (Organon LLC)

  The FDA approved Bilprevda (denosumab) from Organon LLC under an Original Biologics License Application. The product is approved for postmen…

• FDA approval · 2025-10-29
  FDA Approved: ENOBY — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved ENOBY (denosumab-qbde) from Hikma Pharmaceuticals USA Inc. via an original biologics license application. ENOBY is a denosumab …

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• FDA approval · 2025-02-28
  FDA Approved: STOBOCLO — Original Application (CELLTRION USA, Inc.)

  FDA approved STOBOCLO (denosumab-BMWO) from Celltrion USA under an original Biologics License Application for multiple osteoporosis and canc…

• FDA approval · 2024-03-05
  FDA Approved: WYOST — Original Application (Sandoz Inc)

  FDA approved WYOST (denosumab) from Sandoz Inc under an original Biologics License Application.

• FDA approval · 2023-06-05
  FDA Approved: ZOLEDRONIC ACID — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' original application for zoledronic acid, enabling a generic IV bisphosphonate product. This mark…

• FDA approval · 2017-02-02
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for zoledronic acid submitted by Sagent Pharmaceuticals, resulting in an approved labeling change. Z…

• FDA approval · 2016-08-18
  FDA Approved: ZOLEDRONIC ACID — Original Application (Fresenius Kabi USA, LLC)

  FDA approved an Original Application for Zoledronic acid as a generic injectable product from Fresenius Kabi USA, LLC. The approval covers i…

• FDA approval · 2013-06-03
  FDA Approved: ZOLEDRONIC ACID — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s original application for a generic zoledronic acid injectable product.

• FDA approval · 2013-03-04
  FDA Approved: ZOLEDRONIC ACID — Original Application (Mylan Institutional LLC)

  FDA approved an original application for a zoledronic acid generic product manufactured by Mylan Institutional LLC.