Hyperammonemia

• FDA approval · 2026-02-17
  FDA Approved: SODIUM PHENYLBUTYRATE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves an original ANDA for sodium phenylbutyrate by Zydus Pharmaceuticals USA Inc., enabling a generic version of the drug.

• EMA approval · 2024-09-25
  EMA Authorised: Ucedane (carglumic acid) — Eurocept International BV

  The European Medicines Agency has authorised Ucedane (carglumic acid) by Eurocept International BV for the treatment of hyperammonemia due t…

• FDA approval · 2024-05-30
  FDA Approved: CARGLUMIC ACID — Supplemental Application (Eton Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for carglumic acid submitted by Eton Pharmaceuticals, Inc.

• 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 · 2023-07-14
  FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved an original application for sodium phenylacetate and sodium benzoate to treat hyperammonemia due to urea cycle disorders.

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• 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 · 2022-11-01
  FDA Approved: SODIUM PHENYLBUTYRATE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)

  FDA approved Glenmark's generic sodium phenylbutyrate (Original Application) for use in treating patients with urea cycle disorders, expandi…

• FDA approval · 2021-08-05
  FDA Approved: CARBAGLU — Supplemental Application (Recordati Rare Diseases)

  The FDA approved a supplemental application for CARBAGLU (carbaglumic acid) from Recordati Rare Diseases, extending its approved use for pat…

• 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…

• FDA approval · 2021-01-22
  FDA Approved: CARBAGLU — Supplemental Application (Recordati Rare Diseases)

  The FDA approved a supplemental application for CARBAGLU (carglumic acid) from Recordati Rare Diseases. The action pertains to a supplement …

• FDA approval · 2020-08-26
  FDA Approved: CARBAGLU — Supplemental Application (Recordati Rare Diseases)

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

• FDA approval · 2017-05-08
  FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Original Application (MAIA PHARMACEUTICALS, INC)

  FDA approved an original application for the generic combination product sodium phenylacetate and sodium benzoate for the treatment of hyper…

• FDA approval · 2016-08-04
  FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved an original Abbreviated New Drug Application for a generic combination of sodium phenylacetate and sodium benzoate manufactured…

• 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 · 2013-08-05
  FDA Approved: CARBAGLU — Supplemental Application (Recordati Rare Diseases)

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

• FDA approval · 2013-07-22
  FDA Approved: CARBAGLU — Supplemental Application (Recordati Rare Diseases)

  The FDA approved a supplemental application for CARBAGLU (carbaglumic acid) submitted by Recordati Rare Diseases. This action authorizes cha…

• FDA approval · 2013-03-22
  FDA Approved: SODIUM PHENYLBUTYRATE — Original Application (Sigmapharm Laboratories, LLC)

  FDA approves an original application for a generic sodium phenylbutyrate (Sigmapharm Laboratories, LLC) to be used as an ammonia scavenger i…

• 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.