NDAINJECTIONINJECTABLEPriority Review
Approved
Feb 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
BUSULFEX (busulfan) by Otsuka is alkylating activity [moa]. Approved for leukemia, myelodysplastic syndrome, hematopoietic stem cell transplantation. First approved in 1999.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BUSULFEX is an intravenous alkylating agent approved in 1999 for leukemia, myelodysplastic syndrome, and hematopoietic stem cell transplantation conditioning. It works by alkylating DNA, disrupting cancer cell proliferation and enabling bone marrow ablation prior to stem cell transplant. The drug is primarily used in specialized hematologic-oncology and transplant settings.
LOE Approaching
As LOE approaches, BUSULFEX brand team is likely consolidating around regulatory maintenance and generic transition planning; expect smaller commercial teams focused on defending market share against generic busulfan entrants.
Mechanism of Action
Alkylating Activity
Pharmacologic Class:
Alkylating Drug
Indications (3)
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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.