TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

CORTIFOAM

HYDROCORTISONE ACETATE
Gastroenterology Approved 1982-02-10
1
Indication
--
Phase 3 Trials
44
Years on Market

Details

Status
Prescription
First Approved
1982-02-10
Routes
RECTAL
Dosage Forms
AEROSOL, METERED

Companies

Active Ingredient: HYDROCORTISONE ACETATE

CORTIFOAM Approval History

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What CORTIFOAM Treats

1 indications

CORTIFOAM is approved for 1 conditions since its original approval in 1982. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Ulcerative Proctitis
Source: FDA Label

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

CORTIFOAM FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Cortifoam ® is indicated as adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.