Overview
Felbamate is an anticonvulsant drug used in the treatment of epilepsy. In particular, in the adult patient population, it can be employed to treat partial seizures (with and without generalization). Alternatively, it is used to treat partial and generalized seizures associated with Lennox-Gastaut syndrome in children. It has a weak inhibitory effect on GABA receptor binding sites.
Indication
For use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use.
Associated Conditions
- Refractory Partial Onset Seizures
- Status Epilepticus
- Refractory Lennox-Gastaut syndrome
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2017/06/22 | N/A | Recruiting | |||
2002/04/24 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Lifesciences Limited | 70771-1077 | ORAL | 400 mg in 1 1 | 10/4/2023 | |
| Amneal Pharmaceuticals of New York LLC | 53746-734 | ORAL | 400 mg in 1 1 | 12/31/2023 | |
| NORTHSTAR RX LLC | 16714-775 | ORAL | 600 mg in 5 mL | 4/17/2018 | |
| Wallace Pharmaceuticals Inc. | 51525-0430 | ORAL | 400 mg in 1 1 | 2/21/2018 | |
| Alvogen Inc. | 47781-627 | ORAL | 400 mg in 1 1 | 1/29/2015 | |
| Meda Pharmaceuticals Inc. | 0037-0431 | ORAL | 600 mg in 1 1 | 11/14/2011 | |
| Amneal Pharmaceuticals of New York LLC | 53746-735 | ORAL | 600 mg in 1 1 | 12/31/2023 | |
| Amneal Pharmaceuticals LLC | 65162-686 | ORAL | 600 mg in 5 mL | 6/15/2023 | |
| Taro Pharmaceuticals U.S.A., inc. | 51672-4185 | ORAL | 400 mg in 1 1 | 12/15/2023 | |
| Bryant Ranch Prepack | 63629-1944 | ORAL | 600 mg in 1 1 | 9/4/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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