NDAOPHTHALMICOINTMENT
Approved
Mar 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
CILOXAN (ciprofloxacin hydrochloride) by Novartis is clinical pharmacology: systemic absorption: absorption studies in humans with the ciprofloxacin ointment have not been conducted, however, based on studies with ciprofloxacin solution, 0. First approved in 1998.
Drug data last refreshed 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CILOXAN is a topical ophthalmic ointment containing ciprofloxacin hydrochloride, a fluoroquinolone antibiotic approved in 1998. It treats bacterial conjunctivitis by interfering with bacterial DNA gyrase, achieving clinical cure in approximately 75% of patients with positive conjunctival cultures. The formulation achieves minimal systemic absorption (<2.5 ng/mL), making it well-suited for localized ocular therapy.
LOE Approaching
Product is in LOE-approaching phase with moderate competitive pressure (30%), signaling a mature team focused on brand defense and lifecycle extension rather than growth expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY: Systemic Absorption: Absorption studies in humans with the ciprofloxacin ointment have not been conducted, however, based on studies with ciprofloxacin solution, 0.3%, mean maximal concentrations are expected to be less than 2.5 ng/mL. Microbiology: Ciprofloxacin has in vitro…
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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.