THIOGUANINE
Details
- Status
- Prescription
- First Approved
- 1966-01-18
- Routes
- ORAL
- Dosage Forms
- TABLET
THIOGUANINE Approval History
What THIOGUANINE Treats
2 indicationsTHIOGUANINE is approved for 2 conditions since its original approval in 1966. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Nonlymphocytic Leukemia
- Chronic Myelogenous Leukemia
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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.
THIOGUANINE FDA Label Details
ProIndications & Usage
FDA Label (PDF)a) Acute Nonlymphocytic Leukemias TABLOID brand Thioguanine is indicated for remission induction and remission consolidation treatment of acute nonlymphocytic leukemias. However, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity (see WARNINGS and ADVERSE REACTIONS). The response to this agent depends upon the age of the patient (younger patients faring better than older) and whether thioguanine is used in previously treated or previously untreated patients. Reliance upon thioguanine alone is seldom justifi...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.