NDAORALTABLET, EFFERVESCENT
Approved
Jan 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
CETYLEV (acetylcysteine) by R-Pharm US is overdose. Approved for lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults, greater with acute ingestion, from repeated supratherapeutic ingestion (rsi) (). First approved in 2016.
Drug data last refreshed 20h ago
Mechanism of Action
overdose. Acetaminophen doses of 150 mg/kg or greater have been associated with hepatotoxicity. Acetylcysteine probably protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.