Tyrosinemia Type

• EMA approval · 2023-06-05
  EMA Authorised: Nityr (nitisinone) — Cycle Pharmaceuticals (Europe) Ltd

  Nityr (nitisinone) has been authorised in Europe for treatment of tyrosinemias.

• FDA approval · 2023-05-25
  FDA Approved: NITISINONE — Original Application (Eton Pharmaceuticals, Inc.)

  FDA approved a generic version of Nitisinone under an Original Application from Eton Pharmaceuticals, Inc. (ANDA 216201).

• FDA approval · 2016-04-22
  FDA Approved: ORFADIN — Original Application (Swedish Orphan Biovitrum AB (publ))

  FDA approves Orfadin (nitisinone) through the original NDA (NDA206356). The approval supports its use for hereditary tyrosinemia type I.

• CLINICAL_TRIALS trial_result · 2015-03-25
  Clinical Trial Update: Study of NTBC for Tyrosinemia I [NA]

  Completed clinical trial evaluating NTBC (nitisinone) for Tyrosinemia type I.