Nephropathic Cystinosis

• 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.