OXTELLAR XR
Oxtellar XR is an anti-epileptic agent indicated for the treatment of partial-onset seizures. The medication is approved for use in both adult and pediatric patients 6 years of age and older. It serves as a therapeutic option for managing and preventing the spread of seizure activity in the brain.
How OXTELLAR XR Works
The pharmacological activity of this drug is primarily exerted through its 10-monohydroxy metabolite (MHD), which blocks voltage-sensitive sodium channels. This action stabilizes hyperexcited neural membranes and inhibits repetitive neuronal firing, which helps prevent the spread of synaptic impulses. Additionally, the drug may contribute to anticonvulsant effects by increasing potassium conductance and modulating high-voltage activated calcium channels.
Details
- Status
- Prescription
- First Approved
- 2012-10-19
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
OXTELLAR XR Approval History
What OXTELLAR XR Treats
1 indicationsOXTELLAR XR is approved for 1 conditions since its original approval in 2012. 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.
OXTELLAR XR FDA Label Details
ProIndications & Usage
FDA Label (PDF)Oxtellar XR is indicated for the treatment of partial-onset seizures in patients 6 years of age and older. Oxtellar XR® is indicated for the treatment of partial-onset seizures in patients 6 years of age and older.
OXTELLAR XR Patents & Exclusivity
Patents (99 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.