NDATOPICALOIL
Approved
Feb 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
4/8 — Partial
DERMA-SMOOTHE/FS (fluocinolone acetonide) by Eurofarma Laboratórios is corticosteroid hormone receptor agonists [moa]. First approved in 1988.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DERMA-SMOOTHE/FS is a topical corticosteroid oil formulation containing fluocinolone acetonide, a corticosteroid hormone receptor agonist approved in 1988. It is indicated for inflammatory and pruritic dermatologic conditions requiring topical steroid therapy. The drug works by binding corticosteroid receptors to reduce inflammation, itching, and associated skin symptoms.
LOE Approaching
As LOE approaches, the brand team will likely focus on lifecycle management and preparation for generic competition; team size is expected to contract.
Mechanism of Action
Corticosteroid Hormone Receptor Agonists
Pharmacologic Class:
Corticosteroid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
Started Nov 2023
600 enrolled
Radiation RetinopathyVisual Impairment
Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis
Started Jun 2022
125 enrolled
Uveitis, Posterior
Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
Started Jul 2017
3 enrolled
Uveitis, Posterior
Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant
Started Feb 2016
98 enrolled
InflammationUveitis
Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
Started Apr 2011
120 enrolled
Diabetic Macular Edema
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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.