GLIADEL
Details
- Status
- Prescription
- First Approved
- 1996-09-23
- Routes
- INTRACRANIAL
- Dosage Forms
- IMPLANT
GLIADEL Approval History
What GLIADEL Treats
2 indicationsGLIADEL is approved for 2 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glioma
- Glioblastoma
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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.
GLIADEL FDA Label Details
ProIndications & Usage
FDA Label (PDF)GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation, and recurrent glioblastoma as an adjunct to surgery. GLIADEL Wafer is an alkylating drug indicated for the treatment of: newly-diagnosed high-grade glioma as an adjunct to surgery and radiation and recurrent glioblastoma as an adjunct to surgery
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.