Felbamate
Felbatol (felbamate) is a small molecule pharmaceutical. Felbamate was first approved as Felbatol on 1993-07-29. It is used to treat complex partial epilepsy, epilepsy, lennox gastaut syndrome, and seizures in the USA.
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Commercial
Trade Name
FDA
EMA
Felbatol (generic drugs available since 2011-09-13)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Felbamate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FELBATOL | Mylan | N-020189 RX | 1993-07-29 | 3 products, RLD, RS |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| complex partial epilepsy | EFO_1000877 | D017029 | — |
| epilepsy | EFO_0000474 | D004827 | G40.9 |
| lennox gastaut syndrome | — | D065768 | G40.81 |
| seizures | HP_0007359 | D012640 | G40.4 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Herpes genitalis | D006558 | EFO_0007282 | A60 | — | — | 3 | 3 | — | 6 |
| Herpes labialis | D006560 | EFO_1001347 | B00.1 | — | 1 | 1 | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Herpes zoster | D006562 | EFO_0006510 | B02 | — | — | 2 | — | 1 | 3 |
| Herpes simplex | D006561 | B00 | — | 1 | 1 | — | — | 2 | |
| Chickenpox | D002644 | EFO_0007204 | B01 | — | — | 1 | — | — | 1 |
| Meniere disease | D008575 | EFO_0006862 | H81.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 2 | — | — | — | — | 2 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FELBAMATE |
| INN | felbamate |
| Description | Felbamate is the bis(carbamate ester) of 2-phenylpropane-1,3-diol. An anticonvulsant, it is used in the treatment of epilepsy. It has a role as an anticonvulsant and a neuroprotective agent. |
| Classification | Small molecule |
| Drug class | tranquilizers/antiepileptics (propanediol and pentanediol groups) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | NC(=O)OCC(COC(N)=O)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 25451-15-4 |
| RxCUI | 24812 |
| ChEMBL ID | CHEMBL1094 |
| ChEBI ID | 4995 |
| PubChem CID | 3331 |
| DrugBank | DB00949 |
| UNII ID | X72RBB02N8 (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,330 documents
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Safety
Black-box Warning
Black-box warning for: Felbamate, Felbatol
Adverse Events
Top Adverse Reactions
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977 adverse events reported
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