Cystinosis

• EMA approval · 2025-09-08
  EMA Authorised: Procysbi (mercaptamine bitartrate) — Chiesi Farmaceutici S.p.A

  The European Medicines Agency authorised Procysbi (mercaptamine bitartrate) for the treatment of cystinosis, with Chiesi Farmaceutici S.p.A …

• EMA approval · 2025-08-08
  EMA Authorised: Cystadrops (mercaptamine hydrochloride) — Recordati Rare Diseases

  EMA authorised Cystadrops, an eye drop containing mercaptamine hydrochloride, for the treatment of cystinosis; it carries orphan medicine st…

• EMA approval · 2024-12-11
  EMA Authorised: Cystagon (mercaptamine bitartrate) — Recordati Rare Diseases

  The EMA authorised Cystagon (mercaptamine bitartrate) for the treatment of cystinosis, with Recordati Rare Diseases as the marketing authori…

• FDA approval · 2020-08-19
  FDA Approved: CYSTADROPS — Original Application (RECORDATI RARE DISEASES, INC.)

  FDA approves CYSTADROPS (cysteamine hydrochloride) from Recordati Rare Diseases for the treatment of corneal cystine crystal accumulation in…

• FDA approval · 2017-09-24
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc.

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• EMA approval · 2016-07-25
  EMA Refused: Dropcys (mercaptamine) — Lucane Pharma

  The EMA refused marketing authorization for Dropcys (mercaptamine) by Lucane Pharma, for corneal diseases and cystinosis.

• FDA approval · 2015-09-09
  FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)

  The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc.