NDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1979
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — 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. Approved for leukemia, myelodysplastic syndromes. First approved in 1979.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CERUBIDINE (daunorubicin hydrochloride) is a cytotoxic anthracycline chemotherapy agent approved in 1979 for treatment of leukemia and myelodysplastic syndromes. It works by intercalating into DNA, inhibiting topoisomerase II, and inducing DNA strand breaks to kill rapidly dividing cancer cells. The drug is administered intravenously with rapid tissue distribution and extensive hepatic metabolism.
LOE Approaching
As a legacy product approaching loss of exclusivity with minimal linked job postings, career growth on this brand is limited; focus shifts to generic conversion and supply chain management.
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.