QUDEXY XR
Details
- Status
- Prescription
- First Approved
- 2014-03-11
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
QUDEXY XR Approval History
What QUDEXY XR Treats
5 indicationsQUDEXY XR is approved for 5 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Epilepsy
- Partial-Onset Seizures
- Generalized Tonic-Clonic Seizures
- Lennox-Gastaut Syndrome
- Migraine
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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.
QUDEXY XR FDA Label Details
ProIndications & Usage
FDA Label (PDF)QUDEXY XR is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ; adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age and older Preventive treatment of migraine in patients 12 years of age and older 1.1 Monotherapy Epilepsy QUDEXY XR is indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in pa...
QUDEXY XR Patents & Exclusivity
Patents (125 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.