DESOWEN (desonide) · GALDERMA LABS LP
Desonide cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.
Details
- Status
- Prescription
- First Approved
- 1984-12-14
- Routes
- TOPICAL
- Dosage Forms
- CREAM, LOTION, OINTMENT
DESOWEN Approval History
What DESOWEN Treats
1 indicationsDESOWEN is approved for 1 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
DESOWEN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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GALDERMA LABS LP's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02624544 | EMS | Ph 4 | withdrawn | Proton Pump Inhibitors Use in Patients With Psoriasis |
| NCT01542138 | NIADESAH | Ph 4 | completed | Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DESOWEN FDA Label Details
Indications & Usage
Desonide cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.