OXCARBAZEPINE
Oxcarbazepine is an anti-epileptic agent indicated for the treatment of partial-onset seizures. It is approved for use as both monotherapy and adjunctive therapy in adult patients. In pediatric populations, the drug is indicated as monotherapy for children aged 4 to 16 years and as adjunctive therapy for children as young as 2 years of age.
How OXCARBAZEPINE Works
Oxcarbazepine exerts its anti-seizure effects primarily through its 10-monohydroxy metabolite (MHD), which blocks voltage-sensitive sodium channels. This blockade stabilizes hyperexcited neural membranes and inhibits repetitive neuronal firing, which diminishes the propagation of synaptic impulses. These actions work together to prevent the spread of seizures within the brain. The drug may also contribute to anticonvulsant activity by increasing potassium conductance and modulating high-voltage activated calcium channels.
Details
- Status
- Prescription
- First Approved
- 2007-10-09
- Routes
- ORAL, EXTENDED RELEASE
- Dosage Forms
- TABLET, SUSPENSION, TABLET, EXTENDED RELEASE
Companies
OXCARBAZEPINE Approval History
What OXCARBAZEPINE Treats
4 indicationsOXCARBAZEPINE is approved for 4 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-onset seizures in adults (monotherapy)
- Partial-onset seizures in adults (adjunctive therapy)
- Partial-onset seizures in pediatric patients aged 4 to 16 years (monotherapy)
- Partial-onset seizures in pediatric patients aged 2 to 16 years (adjunctive therapy)
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.
OXCARBAZEPINE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine tablets are indicated for: • Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures • Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4 to 16 years - Adjunctive therapy in the treat...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.