NDAINJECTIONINJECTABLEPriority Review
Approved
Nov 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
FLAGYL I.V. (metronidazole hydrochloride) by Pfizer is (metronidazole and tetracycline hydrochloride) and bismuth subcitrate potassium [see microbiology ()] . Approved for duodenal ulcer disease (active, history of within the past 5 years) to eradicate h. First approved in 1980.
Drug data last refreshed 12h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLAGYL I.V. is a metronidazole hydrochloride injection approved by Pfizer for treating active duodenal ulcer disease and H. pylori eradication. It is a small-molecule antimicrobial agent administered intravenously, working through nucleic acid disruption in target pathogens.
LOE Approaching
As a mature product approaching loss of exclusivity with 30% competitive pressure, commercial teams are likely focused on cost management and market consolidation rather than expansion.
Mechanism of Action
(metronidazole and tetracycline hydrochloride) and bismuth subcitrate potassium [see Microbiology ()] .
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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.