NDAINJECTIONINJECTABLE
Lifecycle
Pre-Launch
Clinical Trials
20
Data completeness
3/8 — Basic
LEVOFLOXACIN (levofloxacin; sodium chloride) by R-Pharm US is [see microbiology ( )] . Approved for plague, including pneumonic, septicemic plague and 29 more indications.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Levofloxacin (injectable with sodium chloride) is a fluoroquinolone antibiotic administered by injection for serious bacterial infections including plague, respiratory tract infections, and skin structure infections. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, disrupting DNA replication in gram-positive and gram-negative pathogens. The product is in pre-launch phase under NDA by R-Pharm US.
Pre-Launch
Pre-launch stage offers opportunity to shape go-to-market strategy and build commercial infrastructure from inception; manufacturing operator roles suggest production ramp-up underway.
Mechanism of Action
[see Microbiology ( )] .
Indications (28)
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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.