ZOFRAN
LOE ApproachingNDAORALTABLETPriority Review
Approved
Dec 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 4h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOFRAN (ondansetron) is an oral tablet formulation of a selective 5-HT3 receptor antagonist approved in 1992. It is indicated for prevention and treatment of nausea and vomiting, particularly in oncology, post-operative, and chemotherapy settings. The drug works by blocking serotonin receptors in the chemoreceptor trigger zone and gastrointestinal tract.
LOE Approaching
As LOE approaches, the brand team will likely shift focus to generic transition support, authorized generic strategy, or line extension development to maintain market presence.
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 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
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.