RELAFEN (nabumetone) · GSK
RELAFEN is FDA-approved to treat 2 conditions (same as NABUMETONE).
Details
- Status
- Discontinued
- First Approved
- 1991-12-24
- Routes
- ORAL
- Dosage Forms
- TABLET
RELAFEN Approval History
What RELAFEN Treats
2 indicationsRELAFEN is approved for 2 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as NABUMETONE (same active ingredient).
GSK's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
RELAFEN FDA Label Details
Indications & Usage
FDA Label (PDF)RELAFEN is FDA-approved to treat 2 conditions — same approved indications as NABUMETONE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.