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 |
|---|---|---|---|---|---|
2009/09/28 | Phase 1 | Completed | |||
2009/09/02 | Phase 2 | Completed | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | ||
2009/08/19 | Phase 2 | Completed | |||
2009/07/27 | Phase 1 | Completed | |||
2009/06/23 | Not Applicable | Completed | |||
2009/06/09 | Not Applicable | Completed | |||
2009/05/06 | Phase 2 | Completed | The Epilepsy Study Consortium | ||
2009/04/20 | Phase 1 | Completed | Richard H. Haas | ||
2009/03/17 | Phase 2 | Terminated | |||
2009/03/11 | Phase 1 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-6316 | ORAL | 500 mg in 1 1 | 12/13/2011 | |
| Pharmaceutical Associates, Inc. | 0121-4802 | ORAL | 100 mg in 1 mL | 2/27/2014 | |
| Dr. Reddy's Laboratories Limited | 55111-181 | ORAL | 250 mg in 1 1 | 12/5/2018 | |
| Mylan Institutional Inc. | 51079-821 | ORAL | 500 mg in 1 1 | 12/23/2021 | |
| REMEDYREPACK INC. | 70518-3803 | ORAL | 100 mg in 1 mL | 3/29/2024 | |
| OWP Pharmaceuticals, Inc. | 69102-108 | ORAL | 250 mg in 1 1 | 10/29/2020 | |
| Akorn | 50383-241 | ORAL | 100 mg in 1 mL | 5/26/2022 | |
| NorthStar RxLLC | 16714-034 | ORAL | 250 mg in 1 1 | 3/27/2024 | |
| Sagent Pharmaceuticals | 25021-780 | INTRAVENOUS | 500 mg in 5 mL | 11/30/2020 | |
| Camber Pharmaceuticals, Inc. | 31722-536 | ORAL | 250 mg in 1 1 | 4/2/2024 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LEVESINEAL levetiracetam 1000 mg tablet blister pack | 307950 | Medicine | A | 12/7/2018 | |
| LEVEFINTAIC levetiracetam 500 mg film-coated tablet blister pack | 307944 | Medicine | A | 12/7/2018 | |
| LEVETIRACETAM SPR levetiracetam 250 mg tablet blister pack | 384452 | Medicine | A | 6/11/2022 | |
| NOUMED LEVETIRACETAM levetiracetam 500 mg film coated tablet blister pack | 386412 | Medicine | A | 7/5/2022 | |
| LEVACTAM levetiracetam 500mg film coated tablet blister pack | 177056 | Medicine | A | 4/17/2012 | |
| LEVACTAM levetiracetam 1000mg film coated tablet blister pack | 177055 | Medicine | A | 4/17/2012 | |
| AURO-LEVETIRACETAM 250 levetiracetam 250 mg tablets Bottle | 182830 | Medicine | A | 12/23/2011 | |
| LEVI 1000 levetiracetam 1000 mg tablet blister pack | 168794 | Medicine | A | 6/24/2011 | |
| LEVETIRACETAM-GH levetiracetam 1000 mg tablet blister pack | 161296 | Medicine | A | 7/27/2010 | |
| LEVETIRACETAM-GH levetiracetam 500 mg tablet blister pack | 161295 | Medicine | A | 7/27/2010 |
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