LEVETIRACETAM
Details
- Status
- Prescription
- First Approved
- 2008-11-04
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- TABLET, INJECTABLE, SOLUTION, TABLET, EXTENDED RELEASE
Companies
LEVETIRACETAM Approval History
What LEVETIRACETAM Treats
71 FDA approvalsOriginally approved for its first indication in 2008 . Covers 71 distinct patient populations.
- Other (71)
Other
(71 approvals)- • Approved indication (Nov 2008)
- • Approved indication (Jan 2009)
- • Approved indication (Jan 2009)Letter
- • Approved indication (Feb 2009)
- • Approved indication (Mar 2009)
- • Approved indication (Mar 2009)
- • Approved indication (Mar 2009)
- • Approved indication (Apr 2009)
- • Approved indication (Apr 2009)
- • Approved indication (Oct 2009)
- • Approved indication (Dec 2009)
- • Approved indication (Feb 2010)
- • Approved indication (Mar 2010)
- • Approved indication (May 2010)Letter
- • Approved indication (Jun 2010)
- • Approved indication (Jul 2010)
- • Approved indication (Aug 2010)
- • Approved indication (Sep 2010)
- • Approved indication (Oct 2010)
- • Approved indication (Nov 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Feb 2011)
- • Approved indication (Jun 2011)
- • Approved indication (Aug 2011)
- • Approved indication (Aug 2011)
- • Approved indication (Sep 2011)Letter
- • Approved indication (Oct 2011)
- • Approved indication (Oct 2011)
- • Approved indication (Oct 2011)
- • Approved indication (Dec 2011)
- • Approved indication (Jan 2012)
- • Approved indication (Feb 2012)
- • Approved indication (Apr 2012)
- • Approved indication (Apr 2012)
- • Approved indication (May 2012)
- • Approved indication (May 2012)
- • Approved indication (Jul 2012)
- • Approved indication (Aug 2012)
- • Approved indication (Nov 2012)
- • Approved indication (Feb 2013)
- • Approved indication (May 2013)
- • Approved indication (Jun 2013)
- • Approved indication (Sep 2013)
- • Approved indication (Feb 2015)Label Letter
- • Approved indication (May 2015)
- • Approved indication (Jun 2015)
- • Approved indication (Aug 2015)
- • Approved indication (Sep 2015)Letter
- • Approved indication (Dec 2015)Letter
- • Approved indication (Feb 2016)Label Letter
- • Approved indication (Feb 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Aug 2016)
- • Approved indication (Sep 2016)Letter
- • Approved indication (Sep 2017)
- • Approved indication (Mar 2018)Letter
- • Approved indication (May 2018)
- • Approved indication (Aug 2019)
- • Approved indication (Jun 2020)
- • Approved indication (Nov 2020)
- • Approved indication (Jun 2021)Letter
- • Approved indication (Mar 2022)
- • Approved indication (May 2022)Letter
- • Approved indication (Jul 2022)
- • Approved indication (Oct 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Jun 2023)
- • Approved indication (Nov 2023)
- • Approved indication (Nov 2025) New
- • Approved indication (Dec 2025) 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.
LEVETIRACETAM FDA Label Details
ProIndications & Usage
FDA Label (PDF)Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy 1.1 Partial-Onset Seizures Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy L...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.