TOPIRAMATE
Details
- Status
- Prescription
- First Approved
- 2003-12-17
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, CAPSULE, EXTENDED RELEASE, SOLUTION
Companies
TOPIRAMATE Approval History
What TOPIRAMATE Treats
34 FDA approvalsOriginally approved for its first indication in 2003 . Covers 34 distinct patient populations.
- Other (34)
Other
(34 approvals)- • Approved indication (Dec 2003)Letter
- • Approved indication (Mar 2009)
- • Approved indication (Mar 2009)
- • Approved indication (Apr 2009)Letter
- • Approved indication (Apr 2009)
- • Approved indication (Oct 2009)
- • Approved indication (Jan 2010)
- • Approved indication (Sep 2010)
- • Approved indication (Feb 2013)
- • Approved indication (Sep 2013)
- • Approved indication (Nov 2013)
- • Approved indication (Nov 2017)Letter
- • Approved indication (Feb 2021)Letter
- • Approved indication (Aug 2021)
- • Approved indication (Nov 2022)
- • Approved indication (Feb 2023)Letter
- • Approved indication (Mar 2023)
- • Approved indication (Mar 2023)
- • Approved indication (May 2023)
- • Approved indication (Jun 2023)
- • Approved indication (Aug 2023)
- • Approved indication (Sep 2023)
- • Approved indication (Nov 2023)
- • Approved indication (Dec 2023)
- • Approved indication (Jun 2024)
- • Approved indication (Jul 2024)
- • Approved indication (Jul 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Nov 2024)
- • Approved indication (Dec 2024)
- • Approved indication (May 2025) New
- • Approved indication (Sep 2025) New
- • Approved indication (Jan 2026) New
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.
TOPIRAMATE FDA Label Details
ProIndications & Usage
Topiramate tablets are 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 Topiramate tablets are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-c...
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.