CORTEF
Details
- Status
- Prescription
- First Approved
- 1952-12-15
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, INJECTABLE, SUSPENSION
CORTEF Approval History
What CORTEF Treats
10 indicationsCORTEF is approved for 10 conditions since its original approval in 1952. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adrenocortical Insufficiency
- Congenital Adrenal Hyperplasia
- Thyroiditis
- Hypercalcemia
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Bursitis
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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.
CORTEF FDA Label Details
ProIndications & Usage
FDA Label (PDF)CORTEF Tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rhe...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.