Transfusion-dependent Iron Overload

• FDA approval · 2024-03-05
  FDA Approved: DEFERASIROX — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for deferasirox from Zydus Pharmaceuticals USA Inc., updating the product labeling.

• FDA approval · 2020-07-02
  FDA Approved: DEFERASIROX — Original Application (Ascend Laboratories, LLC)

  FDA approved the original ANDA for a generic deferasirox (DEFERASIROX) from Ascend Laboratories, expanding access to an iron-chelating thera…

• FDA approval · 2020-06-15
  FDA Approved: DEFERASIROX — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal's generic deferasirox (Deferasirox) as an original ANDA for the treatment of transfusion-related iron overload in pa…

• FDA approval · 2020-06-15
  FDA Approved: DEFERASIROX — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves a generic version of deferasirox (Zydus Pharmaceuticals USA) under ANDA211383 for chronic iron overload due to blood transfusio…

• FDA approval · 2019-12-30
  FDA Approved: DEFERASIROX — Original Application (Xiromed, LLC)

  FDA approved Xiromed, LLC's generic deferasirox (DEFERASIROX) through an original ANDA.

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• FDA approval · 2019-11-20
  FDA Approved: DEFERASIROX — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved a generic version of deferasirox (DEFERASIROX) from Alembic Pharmaceuticals Limited under an Original Application for the treat…

• FDA approval · 2018-12-12
  FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Exjade (deferasirox) by Novartis, expanding the labeling for treating chronic iron overload due …