DARAPRIM
Details
- Status
- Prescription
- First Approved
- 1953-01-23
- Routes
- ORAL
- Dosage Forms
- TABLET
DARAPRIM Approval History
What DARAPRIM Treats
1 indicationsDARAPRIM is approved for 1 conditions since its original approval in 1953. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Toxoplasmosis
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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.
DARAPRIM FDA Label Details
ProIndications & Usage
FDA Label (PDF)Treatment of Toxoplasmosis: DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.