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 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CETRAXAL is a ciprofloxacin hydrochloride otic solution approved by the FDA in 2009 for treatment of ear infections. It is a fluoroquinolone antibiotic administered as ear drops that works by inhibiting bacterial DNA gyrase and topoisomerase IV, thereby disrupting bacterial replication. The otic formulation delivers the active ingredient directly to the affected ear tissue.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30), indicating a mature lifecycle phase where commercial teams focus on defending market position against incoming generics.
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
Roles linked to CETRAXAL span frontline clinical staff (nurse practitioners, dental hygienists) who prescribe or recommend the product, as well as supply chain and facilities support roles. This suggests a product integrated into community health and dental care settings with downstream operational dependencies.
Nurse PractitionerDental Hygienist
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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.