GALZIN
Details
- Status
- Prescription
- First Approved
- 1997-01-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE
GALZIN Approval History
What GALZIN Treats
1 indicationsGALZIN is approved for 1 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Wilson's Disease
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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.
GALZIN FDA Label Details
ProIndications & Usage
FDA Label (PDF)Zinc acetate therapy is indicated for maintenance treatment of patients with Wilson’s disease who have been initially treated with a chelating agent (See PRECAUTIONS: Monitoring Patients ).
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.