KEPPRA XR
Details
- Status
- Prescription
- First Approved
- 2008-09-12
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
KEPPRA XR Approval History
What KEPPRA XR Treats
1 indicationsKEPPRA XR is approved for 1 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-Onset Seizures
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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.
KEPPRA XR FDA Label Details
ProIndications & Usage
FDA Label (PDF)KEPPRA XR ® is indicated for the treatment of partial-onset seizures in patients 12 years of age and older. KEPPRA XR is indicated for the treatment of partial-onset seizures in patients 12 years of age and older
KEPPRA XR Patents & Exclusivity
Patents (4 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.