NDAORALTABLET
Approved
Apr 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
FACTIVE (gemifloxacin mesylate) by LG Chem Life Sciences is clinical pharmacology pharmacokinetics the pharmacokinetics of gemifloxacin are approximately linear over the dose range from 40 mg to 640 mg. Approved for infections caused by susceptible strains of the designated microorganisms in the conditions listed below, development of drug-resistant bacteria, maintain the effectiveness of factive and 3 more indications. First approved in 2003.
Drug data last refreshed 15h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FACTIVE (gemifloxacin mesylate) is an oral fluoroquinolone antibiotic approved in 2003 for treating respiratory and urinary tract infections caused by susceptible bacteria. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, rapidly penetrating lung tissue with concentrations exceeding plasma levels by 7-90 fold depending on tissue type.
LOE Approaching
Product approaching loss of exclusivity with minimal current commercial spending signals late-stage maturity; career opportunities focus on generic preparation and lifecycle optimization rather than expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics The pharmacokinetics of gemifloxacin are approximately linear over the dose range from 40 mg to 640 mg. There was minimal accumulation of gemifloxacin following multiple oral doses up to 640 mg a day for 7 days (mean accumulation <20%). Following repeat oral…
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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.