Breast Cancer with Bone Metastases

• 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.

• EMA approval · 2025-09-26
  EMA Authorised: Ibandronic acid Accord (ibandronic acid) — Accord Healthcare S.L.U.

  The EMA authorised Accord Healthcare S.L.U.'s ibandronic acid product under a marketing authorization. The approval covers indications relat…

• FDA approval · 2023-03-07
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for zoledronic acid submitted by Mylan Institutional LLC.

• FDA approval · 2020-02-21
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for Zoledronic acid from Dr. Reddy's Laboratories Limited, authorizing a generic product through…

• FDA approval · 2015-10-19
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (BPI Labs LLC)

  FDA approves a supplemental application for zoledronic acid from BPI Labs LLC under ANDA 202930. This action supports continued availability…

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• FDA approval · 2015-09-21
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for zoledronic acid from Dr. Reddy's Laboratories Limited.

• FDA approval · 2015-04-09
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Dr.Reddy's Laboratories Ltd)

  FDA approved a supplemental application for zoledronic acid from Dr. Reddy's Laboratories Ltd (ANDA 091363), granting regulatory approval of…

• 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.