Iron Overload

• FDA approval · 2017-09-29
  FDA Approved: DEFEROXAMINE MESYLATE — Original Application (Apotex Corp.)

  FDA approved Apotex Corp's generic deferoxamine mesylate (Deferoxamine Mesylate) under an original ANDA for the treatment of iron overload d…

• FDA approval · 2017-05-18
  FDA Approved: JADENU — Original Application (Novartis Pharmaceuticals Corporation)

  The FDA approved Jadenu (deferasirox) from Novartis as an oral iron chelator for chronic iron overload due to blood transfusions. This is th…

• FDA approval · 2016-11-08
  FDA Approved: DEFEROXAMINE MESYLATE — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for deferoxamine mesylate by Hospira, Inc., supporting the availability of a generic product.

• FDA approval · 2016-04-27
  FDA Approved: DESFERAL — Supplemental Application (MITEM PHARMA)

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

• FDA approval · 2015-11-06
  FDA Approved: JADENU — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for JADENU (deferasirox) from Novartis Pharmaceuticals Corporation.

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• FDA approval · 2015-09-09
  FDA Approved: FERRIPROX — Original Application (Chiesi USA, Inc.)

  The FDA granted approval for Ferriprox (deferiprone) to treat iron overload under an original NDA filed by Chiesi USA, Inc.

• FDA approval · 2015-03-30
  FDA Approved: JADENU — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved JADENU (deferasirox) through an Original Application for the treatment of chronic iron overload due to blood transfusions; the …

• FDA approval · 2012-11-15
  FDA Approved: FERRIPROX — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for Ferriprox (deferiprone) filed by Chiesi USA, Inc., to modify/expand the product’s labeling.

• FDA approval · 2012-06-20
  FDA Approved: DEFEROXAMINE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Deferoxamine Mesylate (Deferoxamine) from Fresenius Kabi USA, LLC.

• FDA approval · 2012-04-20
  FDA Approved: FERRIPROX — Supplemental Application (Chiesi USA, Inc.)

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

• CLINICAL_TRIALS approval · 2012-02-09
  Clinical Trial Update: Compassionate Use of Deferiprone for Patients With Thalassemia and Iron-Induced Heart Disease

  Deferiprone has received approval for marketing to treat iron overload in patients with thalassemia and iron-induced heart disease.

• FDA approval · 2011-12-16
  FDA Approved: DESFERAL — Supplemental Application (MITEM PHARMA)

  The FDA approved a supplemental application for DESFERAL (deferoxamine mesylate) submitted by Mitem Pharma.

• FDA approval · 2011-10-14
  FDA Approved: FERRIPROX — Original Application (Chiesi USA, Inc.)

  Ferriprox (deferiprone) has been approved by the FDA under an original application from Chiesi USA, Inc. for the treatment of iron overload …

• FDA approval · 2011-05-27
  FDA Approved: DEFEROXAMINE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for deferoxamine mesylate from Fresenius Kabi USA, LLC.

• FDA approval · 2010-09-07
  FDA Approved: DESFERAL — Supplemental Application (MITEM PHARMA)

  The FDA approved a supplemental application for DESFERAL (deferoxamine mesylate) from MITEM PHARMA, indicating regulatory action to modify/e…

• FDA approval · 2010-01-28
  FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Exjade (deferasirox) from Novartis Pharmaceuticals Corporation.

• FDA approval · 2009-09-15
  FDA Approved: DEFEROXAMINE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Deferoxamine mesylate as a generic product under Original Application by Fresenius Kabi USA, LLC.

• FDA approval · 2009-04-22
  FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Exjade (deferasirox) submitted by Novartis Pharmaceuticals Corporation, resulting in changes…

• FDA approval · 2007-12-14
  FDA Approved: DEFEROXAMINE MESYLATE — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira's supplemental application for Deferoxamine Mesylate, enabling its continued marketing as an iron chelation therapy.

• FDA approval · 2007-04-20
  FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for EXJADE (deferasirox) submitted by Novartis Pharmaceuticals Corporation, resulting in an approved…