NDATOPICALCREAMPriority Review
Approved
Feb 1963
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
4/8 — Partial
Priority Review
SYNALAR (fluocinolone acetonide) by Eurofarma Laboratórios is corticosteroid hormone receptor agonists [moa]. Approved for diabetic macular edema, posterior uveitis, melasma and 2 more indications. First approved in 1963.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYNALAR (fluocinolone acetonide) is a topical corticosteroid cream approved in 1963 that works by agonizing corticosteroid hormone receptors to suppress inflammation. It is indicated for diabetic macular edema, posterior uveitis, melasma, non-infectious uveitis, and acute otitis externa. The drug reduces inflammatory cytokines, edema, and capillary leakage in affected tissues.
LOE Approaching
Product approaching loss of exclusivity with minimal current market spending signals a mature, declining franchise with limited team expansion opportunities.
Mechanism of Action
Corticosteroid Hormone Receptor Agonists
Pharmacologic Class:
Corticosteroid
Indications (5)
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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.