Ethylene Glycol Poisoning
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CLINICAL_TRIALS trial_result · 2025-04-04Clinical Trial Update: Fomepizole Dosing During Continuous Renal Replacement Therapy (CRRT)
Clinical trial update detailing fomepizole dosing during continuous renal replacement therapy for toxic alcohol poisoning, with the study st…
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CLINICAL_TRIALS research · 2024-03-04Clinical Trial Update: Specified Drug-use Survey of Fomepizole Intravenous Infusion (All-case Surveillance)
A completed clinical trial update on the specified drug-use surveillance for fomepizole IV infusion, with results posted.
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FDA approval · 2023-07-06FDA Approved: FOMEPIZOLE — Original Application (Sagent Pharmaceuticals)
FDA approved fomepizole under an original application from Sagent Pharmaceuticals, providing a generic antidote for methanol and ethylene gl…
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FDA approval · 2020-12-23FDA Approved: FOMEPIZOLE — Supplemental Application (Navinta LLC)
FDA approved a supplemental application for fomepizole from Navinta LLC, providing a generic form of the antidote used to treat methanol and…
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FDA approval · 2020-12-23FDA Approved: FOMEPIZOLE — Supplemental Application (American Regent, Inc.)
The FDA approved a supplemental application for Fomepizole from American Regent, Inc., effectively approving continued marketing and labelin…
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FDA approval · 2020-12-23FDA Approved: FOMEPIZOLE — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for fomepizole from Mylan Institutional LLC, authorizing continued marketing and labeling updates fo…
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FDA approval · 2015-03-18FDA Approved: FOMEPIZOLE — Supplemental Application (Navinta LLC)
FDA approved a supplemental Abbreviated New Drug Application for fomepizole from Navinta LLC.
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FDA approval · 2008-03-06FDA Approved: FOMEPIZOLE — Original Application (Navinta LLC)
FDA approved the original application for fomepizole from Navinta LLC, establishing a generic antidote for methanol and ethylene glycol pois…
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FDA approval · 2008-03-03FDA Approved: FOMEPIZOLE — Original Application (Mylan Institutional LLC)
The FDA approved a generic fomepizole product through an original application (ANDA 078639) submitted by Mylan Institutional LLC. The approv…
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FDA approval · 2007-12-14FDA Approved: FOMEPIZOLE — Original Application (American Regent, Inc.)
FDA approves American Regent, Inc.'s original application for fomepizole, the antidote used to treat methanol and ethylene glycol poisoning.