NDAOTICSOLUTION/DROPS
Approved
Dec 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
FLOXIN OTIC (ofloxacin) by Daiichi Sankyo is clinical pharmacology pharmacokinetics: serum, urine and tear concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with ofloxacin ophthalmic solution. First approved in 1997.
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLOXIN OTIC (ofloxacin) is a fluoroquinolone antibiotic ophthalmic solution that treats bacterial conjunctivitis and corneal ulcers by inhibiting bacterial DNA gyrase. It achieves high tear and corneal concentrations while maintaining minimal systemic absorption, enabling effective topical therapy against gram-positive and gram-negative aerobic bacteria.
LOE Approaching
Product approaching loss of exclusivity signals defensive positioning and transition planning; expect focus on cost optimization and legacy brand management over growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics: Serum, urine and tear concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with ofloxacin ophthalmic solution. The mean serum ofloxacin concentration ranged from 0.4 ng/mL to 1.9 ng/mL.…
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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.