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Data updated: Mar 10, 2026

METHSUXIMIDE

METHSUXIMIDE
Neurology Approved 2023-05-01
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2023-05-01
Routes
ORAL
Dosage Forms
CAPSULE

Companies

NOVITIUM PHARMA
Active Ingredient: METHSUXIMIDE

METHSUXIMIDE Approval History

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What METHSUXIMIDE Treats

1 indications

METHSUXIMIDE is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Seizures
Source: FDA Label

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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

METHSUXIMIDE FDA Label Details

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Indications & Usage

INDICATIONS & USAGE Methsuximide is indicated for the control of absence (petit mal) seizures that are refractory to other drugs.

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Data Sources

FDA Approval: ANDA217213 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.