NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1979
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
CERUBIDINE (daunorubicin hydrochloride) by Thayer Medical is clinical pharmacology mechanism of action daunorubicin has antimitotic and cytotoxic activity through a number of proposed mechanisms of action. First approved in 1979.
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CERUBIDINE (daunorubicin hydrochloride) is a cytotoxic anthracycline chemotherapy agent approved in 1979 for hematologic malignancies, primarily acute leukemias. It works by intercalating into DNA, inhibiting topoisomerase II, and inducing single and double-strand DNA breaks. The drug has a rapid tissue uptake with a terminal half-life of 18.5 hours and is extensively metabolized in the liver.
LOE Approaching
Product is in LOE-approaching phase with moderate competitive pressure (30%), suggesting team contraction and transition focus rather than growth opportunity.
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of Action Daunorubicin has antimitotic and cytotoxic activity through a number of proposed mechanisms of action. Daunorubicin forms complexes with DNA by intercalation between base pairs. It inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II…
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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.