NDAORALTABLETPriority Review
Approved
Jul 1963
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
FLAGYL (metronidazole) by Pfizer is clinical pharmacology absorption disposition of metronidazole in the body is similar for both oral and intravenous dosage forms. First approved in 1963.
Drug data last refreshed 14h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLAGYL (metronidazole) is a small-molecule nitroimidazole antibiotic approved in 1963 for treating anaerobic bacterial and protozoal infections. It works by disrupting DNA synthesis in susceptible organisms and is used across 13+ indications including bacterial vaginosis, C. difficile infection, trichomoniasis, and intra-abdominal infections. The drug achieves therapeutic concentrations in plasma, cerebrospinal fluid, saliva, and tissue abscesses with an 8-hour elimination half-life.
LOE Approaching
As a legacy oral antibiotic approaching loss of exclusivity with no patent protections remaining, FLAGYL brand teams face significant generic competition and declining market share, resulting in smaller commercial footprints.
Mechanism of Action
CLINICAL PHARMACOLOGY Absorption Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms. FLAGYL 375 capsules have been shown to have a rate and extent of absorption similar to metronidazole tablets (FLAGYL) and were bioequivalent at an equal single dose of…
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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.