PYRAZINAMIDE
Details
- Status
- Prescription
- First Approved
- 1971-06-03
- Routes
- ORAL
- Dosage Forms
- TABLET
PYRAZINAMIDE Approval History
What PYRAZINAMIDE Treats
1 indicationsPYRAZINAMIDE is approved for 1 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tuberculosis
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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.
PYRAZINAMIDE FDA Label Details
ProIndications & Usage
INDICATIONS & USAGE Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months. *4 ) (Patients with drug-resistant disease should be treated with regimens individualized to their situation. Pyrazinamide frequently will be an important component of s...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.