Wilson Disease

• EMA approval · 2025-07-02
  EMA Authorised: Cufence (trientine dihydrochloride) — Univar Solutions BV

  The EMA authorised Cufence (trientine dihydrochloride) from Univar Solutions BV for Wilson disease (hepatolenticular degeneration). The deci…

• EMA approval · 2024-12-18
  EMA Authorised: Wilzin (zinc) — Recordati Rare Diseases

  The European Medicines Agency authorized Wilzin, a zinc-containing medicine, for Wilson disease (hepatolenticular degeneration) in the EU.

• FDA approval · 2024-04-25
  FDA Approved: GALZIN — Supplemental Application (Eton Pharmaceuticals, Inc.)

  FDA approved a supplemental application for GALZIN (zinc acetate) from Eton Pharmaceuticals, Inc. The document outlines the regulatory submi…

• FDA approval · 2023-09-22
  FDA Approved: TRIENTINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for trientine hydrochloride from Rising Pharma Holdings, Inc. This action updates the regulatory…

• FDA approval · 2022-06-23
  FDA Approved: TRIENTINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' Trientine hydrochloride under an original generic application. The drug is indicated for Wilson disease…

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• FDA approval · 2022-04-28
  FDA Approved: CUVRIOR — Original Application (Orphalan SA)

  FDA approves CUVRIOR (trientine tetrahydrochloride) under an original New Drug Application from Orphalan SA for Wilson disease.

• FDA approval · 2021-10-08
  FDA Approved: PENICILLAMINE — Original Application (Navinta LLC)

  FDA approved Navinta LLC's original application for penicillamine, making this generic available in the U.S. for approved indications such a…

• FDA approval · 2021-08-23
  FDA Approved: PENICILLAMINE — Original Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical's penicillamine under its original application (ANDA 215409), enabling a generic version of pen…

• FDA approval · 2021-03-30
  FDA Approved: TRIENTINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for TRIENTINE HYDROCHLORIDE submitted by Rising Pharma Holdings, Inc.

• FDA approval · 2020-08-04
  FDA Approved: PENICILLAMINE — Original Application (Dr. Reddy's Laboratories Inc.)

  FDA approved Dr. Reddy's Laboratories' original application for penicillamine, a chelating agent used to treat Wilson's disease and cystinur…

• FDA approval · 2020-02-20
  FDA Approved: TRIENTINE HYDROCHLORIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved a generic version of trientine hydrochloride from Rising Pharma Holdings, Inc. for the treatment of Wilson disease.

• FDA approval · 2019-12-23
  FDA Approved: PENICILLAMINE — Original Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s original application for penicillamine as a generic drug product.

• FDA approval · 2019-12-23
  FDA Approved: PENICILLAMINE — Original Application (Endo USA, Inc.)

  The FDA approved Endo USA, Inc.'s generic penicillamine. The generic is approved for the treatment of Wilson disease and rheumatoid arthriti…

• FDA approval · 2019-09-25
  FDA Approved: TRIENTINE HYDROCHLORIDE — Original Application (Endo USA, Inc.)

  The FDA approved Endo USA, Inc.'s original application for trientine hydrochloride, a copper chelator indicated for Wilson disease.

• FDA approval · 2019-07-03
  FDA Approved: TRIENTINE HYDROCHLORIDE — Original Application (Dr.Reddys Laboratories Inc)

  The FDA approved an original application for trientine hydrochloride (ANDA) from Dr. Reddy's Laboratories, enabling its use as a copper-chel…

• FDA approval · 2019-05-22
  FDA Approved: TRIENTINE HYDROCHLORIDE — Original Application (Novadoz Pharmaceuticals LLC)

  FDA approved an original application for trientine hydrochloride from Novadoz Pharmaceuticals LLC, providing a generic option for Wilson dis…

• FDA approval · 2019-01-16
  FDA Approved: TRIENTINE HYDROCHLORIDE — Original Application (Navinta LLC)

  FDA approved Navinta LLC's original application for trientine hydrochloride (a generic drug) via ANDA. This drug is used to treat Wilson dis…

• FDA approval · 2018-02-07
  FDA Approved: TRIENTINE HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved the original application for trientine hydrochloride (Actavis Pharma, Inc.), making the generic product available in the U.S.

• FDA approval · 2016-01-05
  FDA Approved: GALZIN — Supplemental Application (Eton Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for GALZIN (zinc acetate) by Eton Pharmaceuticals.

• FDA approval · 2015-05-22
  FDA Approved: GALZIN — Supplemental Application (Eton Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for GALZIN (zinc acetate) from Eton Pharmaceuticals, Inc.

• FDA approval · 2015-03-03
  FDA Approved: SYPRINE — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for SYPRINE (trientine hydrochloride) submitted by Bausch Health US LLC.

• FDA approval · 2013-08-01
  FDA Approved: GALZIN — Supplemental Application (Eton Pharmaceuticals, Inc.)

  FDA approved a supplemental application for GALZIN (zinc acetate) from Eton Pharmaceuticals, Inc.