TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

EPIPEN

EPINEPHRINE Adrenergic alpha-Agonists
Cardiovascular Approved 1987-12-22
1
Indication
--
Phase 3 Trials
38
Years on Market

Details

Status
Prescription
First Approved
1987-12-22
Routes
INTRAMUSCULAR, SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

Active Ingredient: EPINEPHRINE

EPIPEN Approval History

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What EPIPEN Treats

2 indications

EPIPEN is approved for 2 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Anaphylaxis
  • Allergic Reaction
Source: FDA Label
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Ongoing clinical trials by development phase

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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.

EPIPEN FDA Label Details

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Indications & Usage

FDA Label (PDF)

EpiPen are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a hist...

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Data Sources

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