NDAOTICSOLUTION/DROPS
Approved
Dec 1975
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
CORTISPORIN (hydrocortisone; neomycin sulfate; polymyxin b sulfate) by Monarch Therapeutics is clinical pharmacology colistin sulfate is a polypeptide antibiotic which penetrates into and disrupts the bacterial cell membrane. Approved for superficial bacterial infections of the external auditory canal, caused by organisms susceptible to the action of the antibiotics. First approved in 1975.
Drug data last refreshed 1h ago · AI intelligence enriched 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CORTISPORIN is a fixed-dose combination otic solution containing hydrocortisone (corticosteroid), neomycin sulfate (aminoglycoside antibiotic), and polymyxin B sulfate (polypeptide antibiotic). It treats superficial bacterial infections of the external auditory canal caused by susceptible organisms including Staphylococcus aureus and gram-negative bacteria. The triple-agent mechanism combines anti-inflammatory activity with dual bactericidal coverage to address infection and inflammation simultaneously.
LOE Approaching
As a near-LOE product in a mature, niche otic indication, brand teams face revenue decline and reduced headcount; opportunities lie in defending market share against generics and leveraging established commercial infrastructure.
Mechanism of Action
CLINICAL PHARMACOLOGY Colistin sulfate is a polypeptide antibiotic which penetrates into and disrupts the bacterial cell membrane. Neomycin sulfate is an aminoglycoside antibiotic which inhibits protein synthesis, disrupting the normal cycle of ribosomal function. Hydrocortisone acetate is a…
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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.