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

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Summary

FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc., leading to changes to the product labeling.

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Diseases / indications

• Nephropathic Cystinosis

Drugs mentioned

• Procysbi (mercaptamine bitartrate)

Snippet

SUPPL AP for PROCYSBI (CYSTEAMINE BITARTRATE)