Urea Cycle Disorders
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-04-15FDA Approved: GLYCEROL PHENYLBUTYRATE — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved glycerol phenylbutyrate for urea cycle disorders through an original application. Teva Pharmaceuticals, Inc. is the sponsor.
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FDA approval · 2026-04-15FDA Approved: GLYCEROL PHENYLBUTYRATE — Original Application (Aurobindo Pharma Limited)
FDA approved the original ANDA for glycerol phenylbutyrate, a generic version developed by Aurobindo Pharma Limited.
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FDA approval · 2026-04-15FDA Approved: GLYCEROL PHENYLBUTYRATE — Original Application (Novadoz Pharmaceuticals LLC)
FDA approves an original application for glycerol phenylbutyrate from Novadoz Pharmaceuticals LLC, a generic option for the treatment of ure…
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FDA approval · 2026-02-17FDA 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.
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EMA approval · 2025-12-05EMA Authorised: Ravicti (glycerol phenylbutyrate) — Immedica Pharma AB
The European Medicines Agency granted marketing authorization for Ravicti (glycerol phenylbutyrate) to treat inborn urea cycle disorders, wi…
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FDA approval · 2023-09-29FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for sodium phenylacetate and sodium benzoate from Zydus Pharmaceuticals USA Inc., updating its regul…
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FDA approval · 2023-07-14FDA 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 · 2022-11-01FDA 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…
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FDA approval · 2022-07-29FDA Approved: BUPHENYL — Supplemental Application (Horizon Therapeutics USA, Inc.)
FDA approved a supplemental application for BUPHENYL (sodium phenylbutyrate) from Horizon Therapeutics USA, Inc., resulting in updated label…
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FDA approval · 2021-12-02FDA Approved: GLYCEROL PHENYLBUTYRATE — Original Application (Par Health USA, LLC)
FDA approved the original application for glycerol phenylbutyrate oral to treat patients with urea cycle disorders and help prevent elevated…
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FDA approval · 2021-09-03FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved a supplemental application for glycerol phenylbutyrate submitted by Lupin Pharmaceuticals, Inc.
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FDA approval · 2019-10-04FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for glycerol phenylbutyrate.
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FDA approval · 2018-12-21FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental submission for glycerol phenylbutyrate, a nitrogen-scavenging therapy for urea cycle disord…
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FDA approval · 2017-05-08FDA 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…
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FDA approval · 2017-04-28FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for glycerol phenylbutyrate.
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FDA approval · 2016-09-08FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved a supplemental application for glycerol phenylbutyrate from Lupin Pharmaceuticals, updating or expanding its regulatory sta…
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FDA approval · 2016-08-04FDA 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…
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FDA approval · 2016-06-15FDA Approved: SODIUM PHENYLBUTYRATE — Original Application (ENDO USA, Inc.)
FDA approved an original application for a generic sodium phenylbutyrate from ENDO USA, Inc. for the treatment of urea cycle disorders.
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FDA approval · 2016-04-15FDA Approved: SODIUM PHENYLBUTYRATE — Original Application (ENDO USA, Inc.)
FDA approved the original application for sodium phenylbutyrate tablets, 500 mg, by Endo USA, Inc., establishing a generic version of the dr…
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FDA approval · 2015-10-06FDA Approved: BUPHENYL — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for BUPHENYL (sodium phenylbutyrate) submitted by Horizon Therapeutics USA, Inc.
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FDA approval · 2015-07-27FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for glycerol phenylbutyrate. The drug is used as a nitrogen scavenger for t…
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FDA approval · 2015-01-05FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for glycerol phenylbutyrate by Lupin Pharmaceuticals, extending its regulatory approval.
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FDA approval · 2014-06-24FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for glycerol phenylbutyrate, a drug used to treat urea cycle disorders.
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FDA approval · 2013-08-02FDA Approved: BUPHENYL — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for BUPHENYL (sodium phenylbutyrate) from Horizon Therapeutics USA, Inc.
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FDA approval · 2013-03-22FDA 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…