Hereditary Tyrosinemia Type

• FDA approval · 2025-07-21
  FDA Approved: NITISINONE — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for Nitisinone from Endo USA, Inc., updating regulatory approval for this drug.

• EMA approval · 2025-07-04
  EMA Authorised: Orfadin (nitisinone) — Swedish Orphan Biovitrum International AB

  The European Medicines Agency authorised Orfadin (nitisinone) by Swedish Orphan Biovitrum International AB for hereditary tyrosinemia type I…

• FDA approval · 2025-06-10
  FDA Approved: NITYR — Supplemental Application (Cycle Pharmaceuticals Ltd.)

  The FDA approved a supplemental application for NITYR (nitisinone) by Cycle Pharmaceuticals Ltd. This action updates the approved product an…

• FDA approval · 2024-01-18
  FDA Approved: NITYR — Supplemental Application (Cycle Pharmaceuticals Ltd.)

  FDA approved a supplemental application for NITYR (nitisinone) filed by Cycle Pharmaceuticals Ltd.

• FDA approval · 2022-05-26
  FDA Approved: NITISINONE — Original Application (Analog Pharma)

  The FDA approved Analog Pharma's Original Application for nitisinone, authorizing a generic version of the drug.

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• FDA approval · 2020-09-02
  FDA Approved: NITYR — Supplemental Application (Cycle Pharmaceuticals Ltd.)

  FDA approved a supplemental application for NITYR (nitisinone) from Cycle Pharmaceuticals Ltd. The action confirms approval of changes submi…

• FDA approval · 2019-08-26
  FDA Approved: NITISINONE — Original Application (Endo USA, Inc.)

  FDA approved an original application for nitisinone (Endo USA, Inc.), a generic version of nitisinone for hereditary tyrosinemia type I.

• FDA approval · 2019-05-17
  FDA Approved: ORFADIN — Supplemental Application (Swedish Orphan Biovitrum AB (publ))

  The FDA approved a supplemental application for Orfadin (nitisinone) by Swedish Orphan Biovitrum AB (publ). This action updates the drug's r…

• FDA approval · 2018-11-05
  FDA Approved: NITYR — Supplemental Application (Cycle Pharmaceuticals Ltd.)

  FDA approved a supplemental application for NITYR (nitisinone) from Cycle Pharmaceuticals Ltd. The approval updates the product labeling.

• FDA approval · 2017-09-01
  FDA Approved: ORFADIN — Supplemental Application (Swedish Orphan Biovitrum AB (publ))

  The FDA approved a supplemental application for Orfadin (nitisinone) submitted by Swedish Orphan Biovitrum AB (publ), updating the product l…

• FDA approval · 2017-07-26
  FDA Approved: NITYR — Original Application (Cycle Pharmaceuticals Ltd.)

  The FDA approved NITYR (Nitisinone) as an original NDA from Cycle Pharmaceuticals Ltd. for the treatment of hereditary tyrosinemia type I.

• FDA approval · 2017-06-16
  FDA Approved: ORFADIN — Supplemental Application (Swedish Orphan Biovitrum AB (publ))

  FDA approved a supplemental application for Orfadin (nitisinone) submitted by Swedish Orphan Biovitrum AB (publ).

• FDA approval · 2016-06-13
  FDA Approved: ORFADIN — Supplemental Application (SWEDISH ORPHAN BIOVITRUM AB (PUBL))

  The FDA approved a supplemental application for ORFADIN (nitisinone) submitted by Swedish Orphan Biovitrum AB (publ).

• FDA approval · 2015-06-05
  FDA Approved: ORFADIN — Supplemental Application (SWEDISH ORPHAN BIOVITRUM AB (PUBL))

  FDA approved a supplemental application for Orfadin (nitisinone) submitted by Swedish Orphan Biovitrum AB (publ).

• FDA approval · 2014-10-30
  FDA Approved: ORFADIN — Supplemental Application (SWEDISH ORPHAN BIOVITRUM AB (PUBL))

  The FDA approved a supplemental application for Orfadin (nitisinone) submitted by Swedish Orphan Biovitrum AB (publ).

• FDA approval · 2013-04-02
  FDA Approved: ORFADIN — Supplemental Application (SWEDISH ORPHAN BIOVITRUM AB (PUBL))

  FDA approved a supplemental application for ORFADIN (nitisinone) from Swedish Orphan Biovitrum AB (publ).

• FDA approval · 2013-02-13
  FDA Approved: ORFADIN — Supplemental Application (SWEDISH ORPHAN BIOVITRUM AB (PUBL))

  FDA approves Orfadin's supplemental application for nitisinone filed by Swedish Orphan Biovitrum AB (publ).