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 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLOXIN OTIC (ofloxacin) is a fluoroquinolone antibiotic ophthalmic solution approved in 1997 for treating bacterial conjunctivitis and corneal ulcers. It works by inhibiting bacterial DNA gyrase, an essential enzyme for bacterial DNA replication and repair, making it bactericidal against a broad spectrum of gram-positive and gram-negative aerobic and anaerobic bacteria. The drug achieves high local concentrations in tear fluid and corneal tissue while maintaining minimal systemic exposure.
LOE Approaching
Product is in late-stage lifecycle approaching loss of exclusivity, likely characterized by a lean, defensive team focused on maintaining market share rather than 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.…
Worked on FLOXIN OTIC at Daiichi Sankyo? Share your interview experience or compensation data (+7 days Pro)
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.