SYMJEPI
Details
- Status
- Prescription
- First Approved
- 2017-06-15
- Routes
- INTRAMUSCULAR, SUBCUTANEOUS
- Dosage Forms
- SOLUTION
SYMJEPI Approval History
What SYMJEPI Treats
2 indicationsSYMJEPI is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypotension
- Septic Shock
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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.
SYMJEPI FDA Label Details
ProIndications & 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.
SYMJEPI Patents & Exclusivity
Patents (4 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.