CORTISPORIN
LOE Approachinghydrocortisone acetate; neomycin sulfate; polymyxin b sulfate
NDATOPICALCREAM
Approved
Apr 1963
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
CORTISPORIN (hydrocortisone acetate; 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 1963.
Drug data last refreshed 16h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cortisporin is a topical cream combining hydrocortisone acetate (corticosteroid), neomycin sulfate (aminoglycoside antibiotic), and polymyxin B sulfate (polypeptide antibiotic) for treatment of superficial bacterial infections of the external auditory canal. The dual antibiotic approach provides bactericidal activity against gram-positive and gram-negative organisms, while hydrocortisone controls inflammation and pruritus. It has been a standard-of-care otic treatment since FDA approval in 1963.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), signaling consolidation of support functions and transition toward lifecycle maintenance or phase-out.
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.