NDAOTICSOLUTION/DROPS
Approved
May 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
CETRAXAL (ciprofloxacin hydrochloride) by Salvat is (see 12. First approved in 2009.
Drug data last refreshed 6h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CETRAXAL is a ciprofloxacin hydrochloride otic solution approved for topical ear use to treat bacterial infections of the external auditory canal. It is a fluoroquinolone antibiotic that works by inhibiting bacterial DNA gyrase and topoisomerase IV, disrupting DNA replication and bacterial cell growth. This small-molecule formulation delivers high local concentrations directly to the infection site.
LOE Approaching
As LOE approaches, the brand team is likely consolidating and focusing on managed care defense and retained specialty channels rather than expansion.
Mechanism of Action
(see 12.4 Clinical Pharmacology, Microbiology).
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on CETRAXAL offers career exposure in a stable, mature otic franchise with deep supply chain and healthcare operations involvement. The LOE approaching phase means roles focus on operational excellence, payer management, and transition planning rather than greenfield commercialization opportunities.
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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.