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 4h 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, effective against a broad spectrum of gram-positive and gram-negative pathogens. It is indicated for moderate to severe infections including community-acquired pneumonia, nosocomial pneumonia, acute bacterial sinusitis, skin/soft tissue infections, urinary tract infections, and chronic bacterial prostatitis. The drug is rapidly absorbed orally with ~99% bioavailability and achieves therapeutic concentrations across multiple body compartments.
LOE Approaching
LEVAQUIN is approaching loss of exclusivity in a mature fluoroquinolone market with significant generic competition, signaling potential brand team downsizing and transition to lifecycle management roles.
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.