Urea Cycle Disorder

• FDA approval · 2024-01-19
  FDA Approved: CARBAGLU — Supplemental Application (Recordati Rare Diseases)

  FDA approved a supplemental application for CARBAGLU (carbaglumic acid) submitted by Recordati Rare Diseases.

• FDA approval · 2023-05-04
  FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Supplemental Application (MAIA PHARMACEUTICALS, INC)

  FDA approved a supplemental application for sodium phenylacetate and sodium benzoate from Maia Pharmaceuticals, indicating approval of an ex…

• FDA approval · 2022-07-29
  FDA Approved: BUPHENYL — Supplemental Application (Horizon Therapeutics USA, Inc.)

  FDA approved a supplemental NDA for BUPHENYL (sodium phenylbutyrate) from Horizon Therapeutics USA, Inc., expanding its approved labeling fo…

• FDA approval · 2022-06-17
  FDA Approved: PHEBURANE — Original Application (Medunik USA)

  FDA approved PHEBURANE (sodium phenylbutyrate) under Medunik USA's original NDA for the treatment of urea cycle disorders to prevent hyperam…

• FDA approval · 2021-06-10
  FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Original Application (MAIA PHARMACEUTICALS)

  The FDA approved Maia Pharmaceuticals' original application for sodium phenylacetate and sodium benzoate, a therapy for managing hyperammone…

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• FDA approval · 2016-02-24
  FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Original Application (Omnivium Pharmaceuticals LLC)

  FDA approved Omnivium's generic sodium phenylacetate and sodium benzoate (original application) for treatment of hyperammonemia due to urea …

• FDA approval · 2009-03-31
  FDA Approved: BUPHENYL — Supplemental Application (Horizon Therapeutics USA, Inc.)

  FDA approved a supplemental application for BUPHENYL (sodium phenylbutyrate) submitted by Horizon Therapeutics USA, Inc.