PENTOXIFYLLINE
Details
- Status
- Prescription
- First Approved
- 1997-07-08
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
PENTOXIFYLLINE Approval History
What PENTOXIFYLLINE Treats
3 indicationsPENTOXIFYLLINE is approved for 3 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Intermittent Claudication
- Chronic Occlusive Arterial Disease
- Peripheral Vascular 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.
PENTOXIFYLLINE FDA Label Details
ProIndications & Usage
Pentoxifylline extended-release tablets are indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. Pentoxifylline can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.