Iron Overload

• FDA approval · 2022-02-11
  FDA Approved: JADENU — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for JADENU (deferasirox) submitted by Novartis Pharmaceuticals Corporation. The action updates the l…

• FDA approval · 2021-11-30
  FDA Approved: FERRIPROX — Supplemental Application (Chiesi USA, Inc.)

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

• FDA approval · 2021-04-30
  FDA Approved: FERRIPROX — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for Ferriprox (deferiprone) from Chiesi USA, Inc., signaling an approved modification to its exi…

• FDA approval · 2021-04-30
  FDA Approved: FERRIPROX — Supplemental Application (Chiesi USA, Inc.)

  FDA approved a supplemental application for Ferriprox (deferiprone) from Chiesi USA, Inc., indicating an approved change to the product’s la…

• FDA approval · 2021-03-29
  FDA Approved: DEFERIPRONE — Original Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a generic version of deferiprone (ANDA 213239) from Hikma Pharmaceuticals USA Inc. under an original application.

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• FDA approval · 2021-03-17
  FDA Approved: DEFERASOROX — Original Application (Novadoz Pharmaceuticals LLC)

  The FDA granted approval for the original ANDA application of Deferasorox (deferasirox) by Novadoz Pharmaceuticals LLC as a generic product.…

• FDA approval · 2021-03-01
  FDA Approved: DEFERASIROX — Supplemental Application (Dr. Reddy's Laboratories Inc)

  The FDA approved a supplemental application for Deferasirox submitted by Dr. Reddy's Laboratories Inc, resulting in changes to the product's…

• 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 · 2020-06-16
  FDA Approved: DEFERASIROX — Original Application (Dr. Reddy's Laboratories Inc)

  FDA approves Dr. Reddy's Laboratories' deferasirox generic under ANDA210945 for the treatment of chronic iron overload due to blood transfus…

• FDA approval · 2020-05-19
  FDA Approved: FERRIPROX — Original Application (Chiesi USA, Inc.)

  FDA approved Ferriprox (deferiprone) through the original NDA submitted by Chiesi USA, Inc.

• FDA approval · 2020-04-13
  FDA Approved: DEFERASIROX — Supplemental Application (Xiromed, LLC)

  The FDA approved a supplemental application for deferasirox filed by Xiromed, LLC under an ANDA.

• FDA approval · 2020-03-30
  FDA Approved: DEFERASIROX — Original Application (Ascend Laboratories, LLC)

  FDA approves Deferasirox as an original ANDA submission by Ascend Laboratories, LLC.

• FDA approval · 2020-02-20
  FDA Approved: FERRIPROX — Supplemental Application (Chiesi USA, Inc.)

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

• FDA approval · 2019-12-27
  FDA Approved: DEFERASIROX — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original application for deferasirox from Amneal Pharmaceuticals NY LLC, marking the first generic approval of deferasirox.

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

  FDA approved the Original Application for Deferasirox from Alembic Pharmaceuticals Limited (ANDA211824).

• FDA approval · 2019-11-20
  FDA Approved: DEFERASIROX — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's generic deferasirox tablet under an original ANDA for the treatment of chronic iron overload due to blood …

• FDA approval · 2019-11-20
  FDA Approved: DEFERASIROX — Original Application (Bionpharma Inc.)

  FDA approved Deferasirox as the generic version under an Original Application (ANDA) submitted by Bionpharma Inc.

• 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 · 2019-11-20
  FDA Approved: DEFERASIROX — Original Application (Dr. Reddy's Laboratories Inc)

  FDA approved Dr. Reddy's Laboratories' original application for deferasirox, a generic iron chelator used to treat chronic iron overload in …

• FDA approval · 2019-07-25
  FDA Approved: FERRIPROX — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for Ferriprox (deferiprone) submitted by Chiesi USA, Inc., updating/expanding the product's labe…

• FDA approval · 2019-07-24
  FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)

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

• FDA approval · 2019-02-08
  FDA Approved: DEFERIPRONE — Original Application (Sun Pharmaceutical Industries, Inc.)

  Sun Pharmaceutical Industries received FDA approval for Deferiprone via original ANDA for the iron chelator used to treat iron overload in t…

• FDA approval · 2018-05-11
  FDA Approved: JADENU — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for JADENU (deferasirox) by Novartis Pharmaceuticals Corporation to expand its labeling for iron che…

• FDA approval · 2018-04-20
  FDA Approved: FERRIPROX — Supplemental Application (Chiesi USA, Inc.)

  The FDA approved a supplemental application for Ferriprox (deferiprone) filed by Chiesi USA, Inc., resulting in updated labeling for iron ch…

• FDA approval · 2018-02-16
  FDA Approved: EXJADE — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Exjade (deferasirox) from Novartis Pharmaceuticals Corporation. The approval updates the lab…