NDAINJECTIONINJECTABLEPriority Review
Approved
Jan 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
ZOFRAN (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 18h 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 (4)
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition
Started Oct 2006
26 enrolled
Healthy
Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fed Condition
Started Oct 2006
26 enrolled
Healthy
Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women
Started Mar 2006
515 enrolled
Nausea and Vomiting, PostoperativePostoperative Nausea and Vomiting
Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women
Started Mar 2006
482 enrolled
Nausea and Vomiting, Postoperative
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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.