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Procysbi FDA Approval History

FDA Approved: Yes (First approved April 30, 2013)
Brand name: Procysbi
Generic name: cysteamine bitartrate
Dosage form: Delayed-Release Capsules
Company: Raptor Pharmaceutical Corp.
Treatment for: Nephropathic Cystinosis

Procysbi (cysteamine bitartrate) is a cystine depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.

Development Timeline for Procysbi

DateArticle
Feb 18, 2020ApprovalHorizon Therapeutics plc Announces U.S. FDA Approval of New Dosage Form for Procysbi (Cysteamine Bitartrate) Delayed-Release Oral Granules
Aug 17, 2015ApprovalFDA Approves Expanded Label for Procysbi to Treat Children Aged 2-6 Years With Nephropathic Cystinosis
Apr 30, 2013ApprovalFDA 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

Further information

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