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 12h ago · AI intelligence enriched 14h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Levofloxacin sodium chloride injection is a fluoroquinolone antibiotic indicated for serious infections including plague, community-acquired pneumonia, and skin structure infections. It works by inhibiting bacterial DNA gyrase, disrupting DNA replication in susceptible gram-positive and gram-negative organisms. The product is in pre-launch stage as an NDA by R-Pharm US.
Pre-Launch
Early-stage injectable antibiotic with significant commercial opportunity if approved; will require build-out of medical affairs, regulatory, and commercial operations teams.
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.