NDAINTRAVENOUSINJECTABLEPriority Review
Approved
Jan 2004
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
ACETADOTE (acetylcysteine) by Cumberland Pharmaceuticals is reduction activity [moa]. 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 2004.
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACETADOTE is an intravenous formulation of acetylcysteine, a small-molecule antidote indicated for reducing hepatic injury following acetaminophen overdose in adults. It works through reduction activity, maintaining or restoring glutathione levels to detoxify the reactive metabolite of acetaminophen. The drug is effective for both acute ingestion and repeated supratherapeutic ingestion scenarios.
Peak5.8 years to LOE
Established peak-stage product with mature market presence; team focus likely on market defense and efficiency rather than growth expansion.
Mechanism of Action
Reduction Activity
Pharmacologic Class:
Antidote
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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.