LEVAQUIN
LOE ApproachingNDAORALSOLUTION
Approved
Oct 2004
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 2004.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEVAQUIN (levofloxacin) is a fluoroquinolone antibiotic administered orally or intravenously that inhibits bacterial DNA gyrase and topoisomerase IV, effectively treating moderate-to-severe infections. It is indicated for community-acquired pneumonia, nosocomial pneumonia, acute bacterial sinusitis, skin infections, urinary tract infections, and chronic bacterial prostatitis caused by susceptible gram-positive and gram-negative pathogens. The drug demonstrates rapid oral absorption with ~99% bioavailability and linear, predictable pharmacokinetics across multiple dosing regimens.
LOE Approaching
As a product approaching loss of exclusivity, LEVAQUIN teams are focused on managed decline strategies, cost containment, and portfolio transition activities with reduced commercial headcount.
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.