Iron Overload

• EMA approval · 2026-06-12
  EMA Authorised: Deferasirox Mylan (deferasirox) — Mylan Pharmaceuticals Limited

  The EMA has authorised Deferasirox Mylan for iron overload indications, including beta-thalassemia, with Mylan Pharmaceuticals Limited as th…

• EMA approval · 2026-04-21
  EMA Authorised: Ferriprox (Deferiprone) — Chiesi Farmaceutici S.p.A.

  The European Medicines Agency authorised Ferriprox (deferiprone) from Chiesi Farmaceutici S.p.A. for the treatment of beta-thalassemia and i…

• EMA approval · 2026-02-05
  EMA Authorised: Exjade (deferasirox) — Novartis Europharm Limited

  The EMA authorised Exjade (deferasirox) by Novartis Europharm Limited for beta-thalassemia and iron overload in the European Union.

• FDA approval · 2025-12-11
  FDA Approved: DEFERIPRONE — Original Application (DR. REDDY'S LABORATORIES, INC.)

  FDA approved Dr. Reddy's Laboratories' original application for deferiprone, a generic iron chelator, enabling its marketing in the United S…

• FDA approval · 2025-10-21
  FDA Approved: DEFERASIROX — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Deferasirox from Actavis Pharma, Inc. This action updates the regulatory status of the product.

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• EMA approval · 2025-09-30
  EMA Authorised: Deferasirox Accord (deferasirox) — Accord Healthcare S.L.U.

  The EMA authorised Deferasirox Accord (deferasirox) for treating iron overload and beta-thalassemia.

• EMA approval · 2025-09-29
  EMA Authorised: Deferasirox Mylan (deferasirox) — Mylan Pharmaceuticals Limited

  EMA has authorised Deferasirox Mylan (deferasirox) for treatment of iron overload, including in patients with beta-thalassemia. This marks E…

• FDA approval · 2025-09-08
  FDA Approved: DEFERASIROX — Original Application (Aurobindo Pharma Limited)

  The FDA approved an original ANDA for deferasirox (generic) manufactured by Aurobindo Pharma Limited, expanding access to iron chelation the…

• FDA approval · 2025-08-15
  FDA Approved: DEFERIPRONE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Deferiprone submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2025-05-08
  FDA Approved: DEFEROXAMINE MESYLATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Deferoxamine Mesylate (Hospira, Inc.), a generic iron chelator.

• FDA approval · 2025-03-27
  FDA Approved: DEFERASIROX ORAL — Supplemental Application (Ascend Laboratories, LLC)

  The FDA approved a supplemental application for Deferasirox oral from Ascend Laboratories, LLC, advancing regulatory approval of this iron c…

• FDA approval · 2025-03-26
  FDA Approved: FERRIPROX — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for Ferriprox (deferiprone) filed by Chiesi USA, Inc.

• FDA approval · 2025-03-26
  FDA Approved: DEFERASIROX — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for Deferasirox submitted by Amneal Pharmaceuticals NY LLC. The supplemental filing updates the …

• FDA approval · 2024-11-18
  FDA Approved: DEFERASIROX — Supplemental Application (Ascend Laboratories, LLC)

  FDA approved a supplemental application for Deferasirox (Ascend Laboratories, LLC), granting the requested changes under ANDA210519.

• 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 · 2024-02-05
  FDA Approved: DEFEROXAMINE MESYLATE — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental ANDA for deferoxamine mesylate submitted by Apotex Corp.

• FDA approval · 2023-11-28
  FDA Approved: DEFEROXAMINE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Deferoxamine (deferoxamine mesylate) submitted by Fresenius Kabi USA, LLC.

• FDA approval · 2023-11-14
  FDA Approved: DEFERASIROX — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for deferasirox submitted by Sun Pharmaceutical Industries, Inc., approving changes to the product l…

• FDA approval · 2023-10-23
  FDA Approved: DEFEROXAMINE MESYLATE — Supplemental Application (Hospira, Inc.)

  FDA approves a supplemental application for deferoxamine mesylate (Hospira) under ANDA076019.

• FDA approval · 2023-10-16
  FDA Approved: DEFERASIROX — Original Application (NorthStar Rx LLC)

  FDA approves NorthStar Rx LLC's original generic application for deferasirox, a once-daily oral iron chelator for reducing chronic iron over…

• FDA approval · 2023-09-26
  FDA Approved: DEFERASIROX — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for Deferasirox from Bionpharma Inc. under an ANDA, authorizing an additional regulatory action for …

• FDA approval · 2023-04-28
  FDA Approved: DEFERASIROX ORAL GRANULES — Supplemental Application (EPIC PHARMA, LLC)

  The FDA approved a supplemental application to authorize Deferasirox Oral Granules (DEFERASIROX) from Epic Pharma, LLC, for the treatment of…

• FDA approval · 2022-09-09
  FDA Approved: DESFERAL — Supplemental Application (MITEM PHARMA)

  The FDA approved a supplemental application for DESFERAL (deferoxamine mesylate) by MITEM PHARMA.

• EMA approval · 2022-07-14
  EMA Authorised: Deferiprone Lipomed (Deferiprone) — Lipomed GmbH

  EMA authorised Deferiprone Lipomed for iron overload and beta-thalassemia with Lipomed GmbH as marketing authorisation holder.

• FDA approval · 2022-02-23
  FDA Approved: DEFERASIROX — Original Application (Cipla USA Inc.)

  FDA approves a generic version of deferasirox (Cipla) under an original ANDA application.