NORPACE
Details
- Status
- Prescription
- First Approved
- 1977-09-01
- Routes
- ORAL
- Dosage Forms
- CAPSULE
NORPACE Approval History
What NORPACE Treats
2 indicationsNORPACE is approved for 2 conditions since its original approval in 1977. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ventricular Tachycardia
- Ventricular Arrhythmias
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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.
NORPACE FDA Label Details
ProIndications & Usage
Disopyramide phosphate is indicated for the treatment of documented ventricular arrhythmias such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of disopyramide phosphate, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of disopyramide phosphate treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic d...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.