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Data updated: Mar 10, 2026

EPIPEN JR.

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 JR. Approval History

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What EPIPEN JR. Treats

2 indications

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

  • Hypotension
  • Septic Shock
Source: FDA Label

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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 JR. FDA Label Details

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Indications & Usage

FDA Label (PDF)

Epinephrine is a non-selective alpha and beta adrenergic agonist indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. 1.1 Hypotension associated with Septic Shock Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.

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Data Sources

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