Overview
Levetiracetam is a drug within the pyrrolidine class that is used to treat various types of seizures stemming from epileptic disorders. It was first approved for use in the United States in 1999 and is structurally and mechanistically unrelated to other anti-epileptic drugs (AEDs). Levetiracetam possesses a wide therapeutic index and little-to-no potential to produce, or be subject to, pharmacokinetic interactions - these characteristics make it a desirable choice over other AEDs, a class of drugs notorious for having generally narrow therapeutic indexes and a propensity for involvement in drug interactions.
Indication
Levetiracetam is indicated as an adjunctive therapy in the treatment of partial onset seizures in epileptic patients who are one month of age and older. Additionally, it is indicated as an adjunct in the treatment of myoclonic seizures in patients with juvenile myoclonic epilepsy who are 12 years of age and older, and in primary generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy who are 6 years of age and older. Levetiracetam is also available as an orally dissolvable tablet that is indicated as an adjunct in the treatment of partial onset seizures in patients with epilepsy who are 4 years of age and older and weigh more than 20kg.
Associated Conditions
- Epilepsies
- Generalized Tonic-Clonic Seizures
- Partial-Onset Seizures
- Myoclonic seizures
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/19 | Not Applicable | Not yet recruiting | Ayal A. Aizer, MD | ||
2025/07/18 | Not Applicable | Recruiting | All India Institute of Medical Sciences, Jodhpur | ||
2025/07/04 | Not Applicable | Completed | |||
2025/07/01 | Not Applicable | Recruiting | |||
2025/04/09 | Phase 2 | Recruiting | |||
2025/03/10 | Phase 4 | Recruiting | |||
2025/01/14 | Phase 3 | Recruiting | Shanghai East Hospital | ||
2024/06/04 | Phase 3 | Recruiting | |||
2024/05/07 | Phase 4 | ENROLLING_BY_INVITATION | |||
2024/05/01 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Preferred Pharmaceuticals Inc. | 68788-8577 | ORAL | 500 mg in 1 1 | 2/1/2024 | |
| BluePoint Laboratories | 68001-405 | ORAL | 1000 mg in 1 1 | 12/20/2023 | |
| Rebel Distributors Corp | 21695-016 | ORAL | 1000 mg in 1 1 | 6/22/2010 | |
| Accord Healthcare Inc. | 16729-066 | ORAL | 750 mg in 1 1 | 1/2/2024 | |
| Novadoz Pharmaceuticals LLC | 72205-095 | ORAL | 500 mg in 1 1 | 10/12/2022 | |
| Lupin Pharmaceuticals, Inc. | 68180-115 | ORAL | 1000 mg in 1 1 | 3/12/2024 | |
| REMEDYREPACK INC. | 70518-1623 | ORAL | 500 mg in 1 1 | 2/22/2024 | |
| Amneal Pharmaceuticals LLC | 65162-685 | ORAL | 100 mg in 1 mL | 1/11/2024 | |
| NorthStar RxLLC | 16714-035 | ORAL | 500 mg in 1 1 | 3/27/2024 | |
| Atlantic Biologicals Corps | 17856-0685 | ORAL | 100 mg in 1 mL | 10/14/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/26/2011 | ||
Authorised | 12/4/2011 | ||
Authorised | 12/4/2011 | ||
Authorised | 12/14/2011 | ||
Authorised | 10/3/2011 | ||
Authorised | 9/29/2000 | ||
Authorised | 9/29/2000 | ||
Authorised | 1/7/2014 | ||
Authorised | 10/3/2011 | ||
Authorised | 10/3/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Keppra Oral Solution 100 mg/ml | SIN13225P | SOLUTION | 100 mg/ml | 12/1/2006 | |
| LEVETIRACETAM SANDOZ FILM COATED TABLETS 500MG | SIN14905P | TABLET, FILM COATED | 500mg | 12/17/2015 | |
| JUBLEVET FILM COATED TABLETS 250MG | SIN15550P | TABLET, FILM COATED | 250mg | 9/28/2018 | |
| LEVEVITAE FILM-COATED TABLET 500MG | SIN15145P | TABLET, FILM COATED | 500mg | 1/4/2017 | |
| INTIRACETAM FILM COATED TABLET 250mg | SIN16290P | TABLET, FILM COATED | 250.00 mg | 7/29/2021 | |
| TIETARI TABLET 1000MG | SIN14916P | TABLET, FILM COATED | 1000 mg | 1/4/2016 | |
| LEVETIRACETAM SANDOZ FILM COATED TABLETS 1000MG | SIN14906P | TABLET, FILM COATED | 1000mg | 12/17/2015 | |
| Keppra Concentrate for Solution for Infusion 100 mg/ml | SIN13730P | INFUSION, SOLUTION CONCENTRATE | 500 mg per vial | 11/13/2009 | |
| Epivon film-coated tablets 1000mg | SIN14449P | TABLET, FILM COATED | 1000mg | 11/29/2013 | |
| LEVETIRACETAM-AFT CONCENTRATE SOLUTION FOR INFUSION 500mg/5ml | SIN15436P | INFUSION, SOLUTION CONCENTRATE | 500mg/5mL | 2/27/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| KEPPRA CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/5ML | N/A | N/A | N/A | 7/28/2009 | |
| JUBLEVET TABLETS 500MG | N/A | N/A | N/A | 6/10/2021 | |
| KEPPRA TAB 1000MG | N/A | N/A | N/A | 7/13/2001 | |
| KEPPRA TAB 250MG | N/A | N/A | N/A | 7/13/2001 | |
| KEPPRA TAB 500MG | N/A | N/A | N/A | 7/13/2001 | |
| JUBLEVET TABLETS 1000MG | N/A | N/A | N/A | 6/10/2021 | |
| JUBLEVET TABLETS 250MG | N/A | N/A | N/A | 6/10/2021 | |
| KEPPRA ORAL SOLUTION 100MG/ML | N/A | N/A | N/A | 10/30/2006 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| AURO-LEVETIRACETAM 250 levetiracetam 250 mg tablets blister pack | 182821 | Medicine | A | 12/23/2011 | |
| LEVETOR 1000 levetiracetam 1000mg tablet blister pack | 159040 | Medicine | A | 5/27/2010 | |
| TORRENT LEVETIRACETAM 500 levetiracetam 500mg tablet blister pack | 159042 | Medicine | A | 5/27/2010 | |
| AURO-LEVETIRACETAM levetiracetam 100 mg/mL oral solution bottle | 225918 | Medicine | A | 6/11/2015 | |
| LEVETIRACETAM-AFT levetiracetam 500 mg/5 mL concentrate solution for infusion vial | 218280 | Medicine | A | 11/7/2014 | |
| LEVERIUOL levetiracetam 750 mg film-coated tablet blister pack | 309485 | Medicine | A | 12/7/2018 | |
| LEVESINEAL levetiracetam 250 mg film-coated tablet blister pack | 307953 | Medicine | A | 12/7/2018 | |
| LEVETIRACETAM TIH levetiracetam 1000 mg tablet blister pack | 384457 | Medicine | A | 6/11/2022 | |
| KETRACCORD levetiracetam 500 mg tablet blister pack | 189883 | Medicine | A | 4/20/2012 | |
| LEVETIRACETAM CH levetiracetam 750 mg tablets bottle | 182809 | Medicine | A | 12/23/2011 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| AURO-LEVETIRACETAM | auro pharma inc | 02375257 | Tablet - Oral | 500 MG | 3/15/2012 |
| AG-LEVETIRACETAM | angita pharma inc. | 02485192 | Tablet - Oral | 250 MG | 3/2/2022 |
| RAN-LEVETIRACETAM | ranbaxy pharmaceuticals canada inc. | 02396106 | Tablet - Oral | 250 MG | 3/22/2013 |
| RAN-LEVETIRACETAM | ranbaxy pharmaceuticals canada inc. | 02396114 | Tablet - Oral | 500 MG | 3/22/2013 |
| SANDOZ LEVETIRACETAM | 02461986 | Tablet - Oral | 250 MG | 8/4/2017 | |
| RIVA-LEVETIRACETAM | laboratoire riva inc. | 02482282 | Tablet - Oral | 500 MG | 4/12/2019 |
| PRO-LEVETIRACETAM - 750 | PRO DOC LIMITEE | 02311399 | Tablet - Oral | 750 MG | 10/8/2009 |
| LEVETIRACETAM INJECTION USP | Sterimax Inc | 02527375 | Solution - Intravenous | 100 MG / ML | 8/5/2022 |
| VAN-LEVETIRACETAM | vanc pharmaceuticals inc | 02432382 | Tablet - Oral | 500 MG | 4/4/2016 |
| M-LEVETIRACETAM | mantra pharma inc | 02524562 | Tablet - Oral | 250 MG | 8/23/2022 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| LEVETIRACETAM VIATRIS 500 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 76177 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| LEVETIRACETAM NORMON 1000 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Normon S.A. | 75044 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| TIRBAS 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Alter S.A. | 74895 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LEVETIRACETAM VIATRIS 250 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 76176 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| LEVETIRACETAM ARISTOGEN 750 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 86816 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized | |
| LEVETIRACETAM ACCORD 100 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSION EFG | 75417 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized | |
| LEVETIRACETAM LIDERFARM 500 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Farmalider S.A. | 76280 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LEVETIRACETAM TARBIS FARMA 1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tarbis Farma S.L. | 86139 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LEVETIRACETAM NORMON 250 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Normon S.A. | 75040 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LEVETIRACETAM NORMON 1.500 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA | Laboratorios Normon S.A. | 89946 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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