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 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLAGYL I.V. is a metronidazole hydrochloride injection indicated for H. pylori eradication in active duodenal ulcer disease or recent ulcer history. It is a small-molecule nitroimidazole antibiotic that works by disrupting bacterial DNA synthesis. The drug is administered via intravenous route in hospital and clinical settings.
LOE Approaching
As an aging injectable product approaching loss of exclusivity, FLAGYL I.V. likely supports a maintenance team with limited growth investment.
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.