Procysbi Approval History

  • FDA approved: Yes (First approved April 30th, 2013)
  • Brand name: Procysbi
  • Generic name: cysteamine bitartrate
  • Company: Raptor Pharmaceutical Corp.
  • Treatment for: Nephropathic Cystinosis

Procysbi (cysteamine bitartrate) is a cystine depleting agent indicated for the treatment of nephropathic cystinosis.

FDA Approval History for Procysbi

DateArticle
Apr 30, 2013Approval FDA Approves Procysbi for Nephropathic Cystinosis
Dec 27, 2012Raptor Pharmaceutical Corp. Provides Update on Procysbi NDA Review
Jun 15, 2012Raptor Pharmaceutical Announces FDA Acceptance of New Drug Application for RP103 for the Potential Treatment of Nephropathic Cystinosis
Apr  2, 2012Raptor Pharmaceutical Corp. Submits New Drug Application for RP103 for the Potential Treatment of Nephropathic Cystinosis

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