NDAINJECTIONINJECTABLEPriority Review
Approved
Jan 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
ZOFRAN PRESERVATIVE FREE (ondansetron hydrochloride) by Novartis is 5-ht 3 receptor antagonist. Approved for chemotherapy-induced nausea and vomiting. First approved in 1991.
Drug data last refreshed 19h ago
Mechanism of Action
5-HT 3 receptor antagonist. While ondansetron's mechanism of action has not been fully characterized, it is not a dopamine-receptor antagonist.
Indications (1)
Clinical Trials (2)
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fed Condition
Started Oct 2006
26 enrolled
Healthy
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition
Started Oct 2006
26 enrolled
Healthy
Company
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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.