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FDA approval · 2020-02-14

FDA Approved: PROCYSBI — Original Application (Horizon Therapeutics USA, Inc.)

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Summary

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

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Diseases / indications

Drugs mentioned

  • Procysbi (mercaptamine bitartrate)

Snippet

ORIG AP for PROCYSBI (CYSTEAMINE BITARTRATE)