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 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CERUBIDINE (daunorubicin hydrochloride) is a cytotoxic anthracycline chemotherapy agent that intercalates into DNA and inhibits topoisomerase II, causing single and double-strand DNA breaks. It is indicated for acute leukemias and lymphomas across pediatric and adult populations. The drug demonstrates broad antitumor activity through multiple mechanisms including DNA intercalation, topoisomerase inhibition, polymerase interference, and free radical generation.
LOE Approaching
As loss of exclusivity approaches, the brand team will shift focus from growth initiatives to cost management, generic defense strategies, and organizational consolidation.
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.