ETHAMOLIN
Details
- Status
- Prescription
- First Approved
- 1988-12-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ETHAMOLIN Approval History
What ETHAMOLIN Treats
1 indicationsETHAMOLIN is approved for 1 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Esophageal Varices
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.
ETHAMOLIN FDA Label Details
ProIndications & Usage
ETHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent rebleeding. ETHAMOLIN is not indicated for the treatment of patients with esophageal varices that have not bled. There is no evidence that treatment of this population decreases the likelihood of bleeding. Sclerotherapy with ETHAMOLIN has no beneficial effect upon portal hypertension, the cause of esophageal varices, so that recanalization and collateralization may occur, necessitating reinjection.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.