NDAORALCAPSULE
Approved
May 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
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 1995.
Drug data last refreshed 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLAGYL (metronidazole) is an oral nitroimidazole antimicrobial small molecule approved in 1995 for treating bacterial vaginosis, trichomonas infections, and intra-abdominal infections. The drug works by disrupting anaerobic bacterial and parasitic DNA, with peak plasma concentrations achieved within 1.6 hours of oral administration and a half-life of approximately 8 hours.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30), signaling potential team downsizing and transition to generic defense strategies.
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.