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Derma-Smoothe/Fs (FLUOCINOLONE ACETONIDE)
Derma-Smoothe/Fs (generic name: FLUOCINOLONE ACETONIDE) is a Corticosteroid [EPC] Small molecule drug developed by Eurofarma. It is currently FDA-approved (first approved 1963) for Atopic dermatitis, Chloasma, Choroiditis.
Derma-Smoothe/FS (Fluocinolone Acetonide) is a corticosteroid medication originally developed by Medimetrics Pharms and currently owned by Eurofarma. It targets the glucocorticoid receptor to treat various skin conditions, including atopic dermatitis, contact dermatitis, and discoid lupus erythematosus. As an off-patent medication, it is available from multiple generic manufacturers. Key safety considerations include potential skin thinning and increased risk of infections. This medication has been FDA-approved since 1963.
At a glance
| Generic name | FLUOCINOLONE ACETONIDE |
|---|---|
| Sponsor | Eurofarma |
| Drug class | Corticosteroid [EPC] |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1963 |
Approved indications
- Atopic dermatitis
- Chloasma
- Choroiditis
- Contact dermatitis
- Discoid lupus erythematosus
- Eruption of skin
- Granuloma annulare
- Lichen simplex chronicus
- Otitis Externa Eczema
- Pityriasis simplex
- Plaque psoriasis
- Primary cutaneous T-cell lymphoma
- Pruritus ani
- Pruritus of genital organs
- Scalp psoriasis
- Seborrheic dermatitis
Common side effects
- burning
- itching
- irritation
- dryness
- folliculitis
- hypertrichosis
- acneiform eruptions
- hypopigmentation
- perioral dermatitis
- allergic contact dermatitis
- maceration of the skin
- secondary infection
Key clinical trials
- The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% FAO in the Management of Oral Lichen Planus (NA)
- Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant
- Imaging of Uveitis Patients Receiving Injectable Fluocinolone Acetonide Implant
- Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy (PHASE3)
- Comparison of Efficacy of Metformin Gel 30% vs Triple Combination Cream (Hydroquinone 4%, Flucinolone Acetonide 0.01%, Tretinoin 0.025%) in Treatment of Melasma in Tertiary Care Hospital Karachi (NA)
- A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (PHASE3)
- Baricitinib Versus Azathioprine in Patients With Moderate-to-Severe Atopic Dermatitis (NA)
- Effect of Lidocaine-Dexmedetomidine on Pain, Inflammation, and Oxidative Stress After Bariatric Surgery. (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 7998108 | 2028-01-12 | Formulation |
| 9849027 | 2028-11-07 | Formulation |
| 8871241 | 2027-08-12 | Formulation |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Derma-Smoothe/Fs CI brief — competitive landscape report
- Derma-Smoothe/Fs updates RSS · CI watch RSS
- Eurofarma portfolio CI
Frequently asked questions about Derma-Smoothe/Fs
What is Derma-Smoothe/Fs?
What is Derma-Smoothe/Fs used for?
Who makes Derma-Smoothe/Fs?
What is the generic name of Derma-Smoothe/Fs?
What drug class is Derma-Smoothe/Fs in?
When was Derma-Smoothe/Fs approved?
What development phase is Derma-Smoothe/Fs in?
What are the side effects of Derma-Smoothe/Fs?
What does Derma-Smoothe/Fs target?
Related
- Drug class: All Corticosteroid [EPC] drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: Eurofarma — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Atopic dermatitis
- Indication: Drugs for Chloasma
- Indication: Drugs for Choroiditis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing