LEVAQUIN
LOE ApproachingNDAORALTABLET
Approved
Dec 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
LEVAQUIN by Johnson & Johnson is [see microbiology(12. Approved for moderate, severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section, nosocomial pneumonia due to methicillinsusceptible staphylococcus aureus and 36 more indications. First approved in 1996.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEVAQUIN (levofloxacin) is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, effectively treating moderate to severe infections across respiratory, urinary, skin, and bone indications. It is available as an oral tablet and solution with near-complete bioavailability (99%), making it suitable for switch therapy from IV formulations. The drug covers a broad spectrum of gram-positive and gram-negative pathogens including Streptococcus pneumoniae, Pseudomonas aeruginosa, and methicillin-susceptible Staphylococcus aureus.
LOE Approaching
Product is in late-stage lifecycle with declining exclusivity; commercial teams will focus on defending market share against generics and newer agents.
Mechanism of Action
[see Microbiology(12.4)]. 12.3 Pharmacokinetics The mean ±SD pharmacokinetic parameters of levofloxacin determined under single and steady-state conditions following oral tablet, oral solution, or intravenous (IV) doses of levofloxacin are summarized in Table 8. Table 8: Mean ±SD Levofloxacin PK…
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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.