STATROL
LOE ApproachingNDAOPHTHALMICOINTMENT
Approved
Mar 1974
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
STATROL by Alcon is clinical pharmacology the anti-infective components in statrol ophthalmic ointment provide action against specific organisms susceptible to them. Approved for the topical treatment of infections of the external eye, its adnexa caused by susceptible bacteria. First approved in 1974.
Drug data last refreshed 11h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
STATROL is a topical ophthalmic ointment combining polymyxin B sulfate and neomycin sulfate for treatment of external eye infections caused by susceptible bacteria. It provides broad-spectrum coverage against gram-negative organisms including Pseudomonas aeruginosa and Staphylococcus aureus, but lacks activity against streptococci and serratia. This is a legacy small-molecule antibiotic product approved nearly 50 years ago.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); expect headcount rationalization and transition focus toward generic supply chain or brand transition strategies.
Mechanism of Action
CLINICAL PHARMACOLOGY The anti-infective components in STATROL Ophthalmic Ointment provide action against specific organisms susceptible to them. Polymyxin B Sulfate and Neomycin Sulfate are active in vitro against Staphylococcus aureus, Escherichia coli, Klebsiella/Enterobacter species, Neisseria…
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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.