LAMICTAL XR
Details
- Status
- Prescription
- First Approved
- 2009-05-29
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
LAMICTAL XR Approval History
What LAMICTAL XR Treats
2 indicationsLAMICTAL XR is approved for 2 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Generalized Tonic-Clonic Seizures
- Partial-Onset Seizures
LAMICTAL XR Boxed Warning
SERIOUS SKIN RASHES LAMICTAL XR can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (aged 2 to 16 years) receiving immediate-release lamotrigine as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years)...
WARNING: SERIOUS SKIN RASHES LAMICTAL XR can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (aged 2 to 16 years) receiving immediate-release lamotrigine as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking adjunctive immediate release lamotrigine, there was 1 rash-related death. LAMICTAL XR is not approved for patients younger than 13 years. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate. The risk of serious rash caused by treatment with LAMICTAL XR is not expected to differ from that with immediate-release lamotrigine. However, the relatively limited treatment experience with LAMICTAL XR makes it difficult to characterize the frequency and risk of serious rashes caused by treatment with LAMICTAL XR. In addition to age, factors that may increase the risk of occurrence or the severity of rash caused by LAMICTAL XR include (1) coadministration of LAMICTAL XR with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of LAMICTAL XR, (3) exceeding the recommended dose escalation for LAMICTAL XR. , or (4) the presence of the HLA-B*1502 allele. However, cases have occurred in the absence of these factors. Nearly all cases of life-threatening rashes caused by immediate-release lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). Accordingly, duration of therapy cannot be relied upon as means to predict the potential risk heralded b
Drugs Similar to LAMICTAL XR
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
LAMICTAL XR FDA Label Details
ProIndications & Usage
FDA Label (PDF)LAMICTAL XR is indicated for: • adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. • conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. 1.1 Adjunctive Therapy LAMICTAL XR is indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and...
WARNING: SERIOUS SKIN RASHES LAMICTAL XR can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (aged 2 to 16 years) receiving immediat...
LAMICTAL XR Patents & Exclusivity
Patents (36 active)
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.