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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/01/02 | Phase 4 | Withdrawn | |||
2007/12/19 | Phase 2 | Completed | |||
2007/12/11 | Phase 4 | Completed | |||
2007/12/03 | Not Applicable | Completed | |||
2007/11/30 | Phase 3 | Terminated | Rennes University Hospital | ||
2007/11/26 | Phase 3 | Terminated | |||
2007/10/16 | Phase 2 | Completed | |||
2007/10/16 | Phase 2 | Completed | |||
2007/10/12 | Phase 3 | UNKNOWN | Scienze Neurologiche Ospedaliere | ||
2007/10/01 | Phase 3 | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| American Health Packaging | 68084-882 | ORAL | 750 mg in 1 1 | 12/8/2023 | |
| SOHM, Inc. | 50405-301 | ORAL | 500 mg in 1 1 | 9/19/2025 | |
| SOHM, Inc. | 50405-300 | ORAL | 250 mg in 1 1 | 9/19/2025 | |
| ACI Healthcare USA, Inc. | 71093-125 | ORAL | 750 mg in 1 1 | 1/17/2023 | |
| REMEDYREPACK INC. | 70518-3769 | ORAL | 100 mg in 1 mL | 3/29/2024 | |
| Baxter Healthcare Corporation | 36000-354 | IONTOPHORESIS, INTRAVENOUS | 15 mg in 1 mL | 5/6/2024 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7977 | ORAL | 500 mg in 1 1 | 11/8/2023 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4142 | ORAL | 500 mg in 1 1 | 7/17/2020 | |
| TRIPOINT THERAPEUTICS, LLC | 80705-100 | ORAL | 1000 mg in 1 1 | 3/25/2024 | |
| BluePoint Laboratories | 68001-404 | ORAL | 750 mg in 1 1 | 12/20/2023 |
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
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| No HSA approvals found for this drug. | |||||
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
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Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| LEVETIRACETAM TARBIS 250 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tarbis Farma S.L. | 76800 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LAURAK 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Neuraxpharm Spain S.L. | 75896 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LAURAK 100 MG/ML SOLUCION ORAL EFG | Neuraxpharm Spain S.L. | 84280 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LEVETIRACETAM BRILL PHARMA 1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Brill Pharma S.L. | 76426 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LEVETIRACETAM RATIOPHARM 500 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 11702014 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| LEVETIRACETAM KRKA 1000 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Krka D.D. Novo Mesto | 78935 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LEVETIRACETAM PENSA 1000 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Towa Pharmaceutical S.A. | 75087 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LEVETIRACETAM TARBIS 100 MG/ML SOLUCION ORAL EFG | Tarbis Farma S.L. | 76801 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LEVETIRACETAM AUROVITAS 250 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Aurovitas Spain, S.A.U. | 81583 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LEVETIRACETAM QUALIGEN 750 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG | Neuraxpharm Spain S.L. | 89239 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
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| No Saudi SFDA approvals found for this drug. | |||||
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