Nephropathic Cystinosis

• FDA approval · 2022-02-11
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc., resulting in a label u…

• FDA approval · 2020-06-24
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc.

• FDA approval · 2020-04-24
  FDA Approved: CYSTARAN — Supplemental Application (Leadiant Biosciences, Inc.)

  The FDA has approved a supplemental application for CYSTARAN (cysteamine hydrochloride) from Leadiant Biosciences, Inc., indicating an appro…

• FDA approval · 2020-02-14
  FDA Approved: PROCYSBI — Original Application (Horizon Therapeutics USA, Inc.)

  The FDA approved Horizon Therapeutics' PROCYSBI (cysteamine bitartrate) through the original NDA 213491 for the treatment of nephropathic cy…

• FDA approval · 2019-05-31
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc.

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• FDA approval · 2017-11-21
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc., resulting in updated l…

• FDA approval · 2016-06-06
  FDA Approved: CYSTAGON — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for CYSTAGON (cysteamine bitartrate) submitted by Mylan Pharmaceuticals. The approval updates the pr…

• FDA approval · 2016-05-13
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc. The action constitutes an N…

• FDA approval · 2016-03-21
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc., marking an approved mo…

• FDA approval · 2016-03-10
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) submitted by Horizon Therapeutics USA, Inc.

• FDA approval · 2015-08-14
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  FDA approves a supplemental application for PROCYSBI (cysteamine bitartrate) submitted by Horizon Therapeutics USA, Inc.

• FDA approval · 2015-06-15
  FDA Approved: CYSTAGON — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for CYSTAGON (cysteamine bitartrate) submitted by Mylan Pharmaceuticals Inc.

• FDA approval · 2015-04-08
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc.

• FDA approval · 2014-12-02
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) filed by Horizon Therapeutics USA, Inc.

• FDA approval · 2014-04-21
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  FDA approved a Supplemental Application for PROCYSBI (cysteamine bitartrate) by Horizon Therapeutics USA, Inc.

• FDA approval · 2014-01-30
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) submitted by Horizon Therapeutics USA, Inc.

• FDA approval · 2013-10-31
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for Procysbi (cysteamine bitartrate) submitted by Horizon Therapeutics USA, Inc.

• FDA approval · 2013-10-18
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for Procysbi (cysteamine bitartrate) from Horizon Therapeutics USA, Inc.

• FDA approval · 2013-10-08
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc.

• FDA approval · 2013-04-30
  FDA Approved: PROCYSBI — Original Application (Horizon Therapeutics USA, Inc.)

  The FDA approved PROCYSBI (cysteamine bitartrate) under an original application for the treatment of nephropathic cystinosis, providing a ne…

• FDA approval · 2012-10-02
  FDA Approved: CYSTARAN — Original Application (Leadiant Biosciences, Inc.)

  The FDA approved CYSTARAN (cysteamine hydrochloride) under its original application from Leadiant Biosciences, Inc. for treating corneal cys…

• FDA approval · 2007-06-06
  FDA Approved: CYSTAGON — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approves a supplemental application for Cystagon (cysteamine bitartrate) filed by Mylan Pharmaceuticals Inc.