PROCTOFOAM HC (hydrocortisone acetate)
PROCTOFOAM HC is indicated for the treatment of Dermatoses.
Details
- Status
- Prescription
- First Approved
- 1978-07-26
- Routes
- TOPICAL
- Dosage Forms
- AEROSOL, METERED
PROCTOFOAM HC Approval History
What PROCTOFOAM HC Treats
1 indicationsPROCTOFOAM HC is approved for 1 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dermatoses
PROCTOFOAM HC 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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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02671058 | CINC-2015-BA | Ph 1 | completed | Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Suppositories |
| NCT02689856 Hydro/Lido | 143-6151-201 | Ph 2 | completed | Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids |
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.
PROCTOFOAM HC FDA Label Details
Indications & Usage
PROCTOFOAM HC is indicated for the treatment of Dermatoses.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.