NDAORALTABLET
Approved
Sep 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
ANZEMET (dolasetron mesylate) by Bausch Health is clinical pharmacology dolasetron mesylate and its active metabolite, hydrodolasetron (mdl 74,156), are selective serotonin 5-ht 3 receptor antagonists not shown to have activity at other known serotonin receptors and with low affinity for dopamine receptors. Approved for nausea, vomiting associated with moderately emetogenic cancer chemotherapy, including initial and 3 more indications. First approved in 1997.
Drug data last refreshed 13h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ANZEMET (dolasetron mesylate) is a selective serotonin 5-HT3 receptor antagonist indicated for prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults and children 2 years and older. It works by blocking serotonin receptors on vagal nerve terminals and in the chemoreceptor trigger zone, preventing the vomiting reflex triggered by chemotherapy-induced serotonin release.
LOE Approaching
ANZEMET faces significant commercial headwinds as a generic-at-risk asset with LOE approaching, meaning field and brand teams will likely experience consolidation and shift toward generic management or other oncology support roles.
Mechanism of Action
CLINICAL PHARMACOLOGY Dolasetron mesylate and its active metabolite, hydrodolasetron (MDL 74,156), are selective serotonin 5-HT 3 receptor antagonists not shown to have activity at other known serotonin receptors and with low affinity for dopamine receptors. The serotonin 5-HT 3 receptors are…
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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.