ZOFRAN
LOE ApproachingNDAINJECTIONINJECTABLEPriority Review
Approved
Jan 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 1h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOFRAN (ondansetron) is an injectable 5-HT3 receptor antagonist approved in 1991 for prevention and treatment of nausea and vomiting, particularly in oncology and post-operative settings. It works by blocking serotonin signals in the chemoreceptor trigger zone and gastrointestinal tract. This is a foundational antiemetic with broad clinical utility across multiple therapeutic areas.
LOE Approaching
As LOE approaches, the brand team is likely focused on lifecycle extension, cost management, and transition planning rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Casopitant (Oral) And ZOFRAN To Prevent Postoperative Nausea And Vomiting In Women
Started Mar 2006
482 enrolled
Nausea and Vomiting, Postoperative
Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women
Started Mar 2006
515 enrolled
Nausea and Vomiting, PostoperativePostoperative Nausea and Vomiting
Food Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg
Started Jul 2005
28 enrolled
Healthy
Fasting Study of Ondansetron Orally Disintegrating Tablets 8 mg to Zofran ODT® Tablets 8 mg
Started Jul 2005
28 enrolled
Healthy
Fasting Study of Ondansetron Tablets 24 mg and Zofran® Tablets 24 mg
Started Jul 2003
28 enrolled
Healthy
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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.