Acetaminophen Poisoning

• CLINICAL_TRIALS trial_result · 2025-11-25
  Clinical Trial Update: Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose [Phase 2]

  A Phase 2 trial evaluating fomepizole for acetaminophen overdose was terminated; no efficacy results are reported.

• FDA approval · 2025-07-23
  FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved Cumberland Pharmaceuticals' supplemental application for ACETADOTE (acetylcysteine), updating the product labeling to reflect t…

• FDA approval · 2024-11-26
  FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Acetadote (acetylcysteine) submitted by Cumberland Pharmaceuticals.

• CLINICAL_TRIALS trial_result · 2013-05-08
  Clinical Trial Update: Effect on Acetaminophen Metabolism by Liquid Formulations [NA]

  The study evaluated whether liquid formulations of acetaminophen affect its metabolism, with results posted after completion in 2013.

• FDA approval · 2012-06-21
  FDA Approved: ACETYLCYSTEINE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Acetylcysteine from Fresenius Kabi USA, LLC under an Original Application (ANDA).

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