Data updated: Mar 10, 2026
LACOSAMIDE
LACOSAMIDE
Approved 2022-03-17
34
Indications
--
Phase 3 Trials
3
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2022-03-17
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- SOLUTION, TABLET
Companies
AMNEAL PHARMS Sun Pharma REGCON HOLDINGS Fresenius Kabi Dr. Reddy's Teva GLENMARK PHARMS LTD Apotex KANCHAN HLTHCARE Aurobindo Pharma ZYDUS PHARMS ALKEM LABS LTD ANTHEA PHARMA HETERO LABS LTD V HETERO LABS LTD III MSN WESTMINSTER PHARMS AJENAT PHARMS ACCORD HLTHCARE SCIEGEN PHARMS SOMERSET THERAPS LLC CHARTWELL RX ACELLA MSN LABS PVT LTD ALEMBIC MACLEODS PHARMS LTD GLAND NOVITIUM PHARMA ASPIRO UNICHEM Hikma HAINAN POLY
Active Ingredient: LACOSAMIDE
Website: ↗
LACOSAMIDE Approval History
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What LACOSAMIDE Treats
34 FDA approvalsOriginally approved for its first indication in 2022 . Covers 34 distinct patient populations.
- Other (34)
Other
(34 approvals)- • Approved indication (Mar 2022)
- • Approved indication (Mar 2022)
- • Approved indication (Apr 2022)
- • Approved indication (May 2022)
- • Approved indication (May 2022)Letter
- • Approved indication (May 2022)
- • Approved indication (Jun 2022)
- • Approved indication (Jul 2022)
- • Approved indication (Aug 2022)
- • Approved indication (Sep 2022)
- • Approved indication (Sep 2022)
- • Approved indication (Sep 2022)
- • Approved indication (Sep 2022)
- • Approved indication (Jan 2023)
- • Approved indication (Feb 2023)
- • Approved indication (Feb 2023)
- • Approved indication (Nov 2023)
- • Approved indication (Dec 2023)
- • Approved indication (Dec 2023)
- • Approved indication (Jan 2024)
- • Approved indication (Feb 2024)
- • Approved indication (Mar 2024)
- • Approved indication (Mar 2024)
- • Approved indication (Apr 2024)
- • Approved indication (Apr 2024)
- • Approved indication (May 2024)
- • Approved indication (May 2024)
- • Approved indication (Sep 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Nov 2024)
- • Approved indication (May 2025) New
- • Approved indication (Jun 2025) New
- • Approved indication (Jan 2026) New
- • Approved indication (Jan 2026) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
LACOSAMIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.