NDAORALSUSPENSIONPriority Review
Approved
Jul 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
Priority Review
FELBATOL (felbamate) by Viatris is mechanism of action the mechanism by which felbamate exerts its anticonvulsant activity is unknown, but in animal test systems designed to detect anticonvulsant activity, felbamate has properties in common with other marketed anticonvulsants. Approved for epilepsy, anemia. First approved in 1993.
Drug data last refreshed 3h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FELBATOL (felbamate) is an oral anti-epileptic agent approved in 1993 for the treatment of epilepsy and anemia. The mechanism of action remains incompletely understood, but felbamate exhibits anticonvulsant properties through weak GABA and benzodiazepine receptor interactions and antagonism at the glycine recognition site of the NMDA receptor. It is effective against generalized tonic-clonic, partial, and absence seizures in preclinical models.
$7MPart D
LOE ApproachingDeclining
With LOE approaching and modest Part D spending of $7M annually, this product faces significant generic erosion; brand team size is likely minimal or transitioning to legacy management.
Mechanism of Action
Mechanism of Action The mechanism by which felbamate exerts its anticonvulsant activity is unknown, but in animal test systems designed to detect anticonvulsant activity, felbamate has properties in common with other marketed anticonvulsants. Felbamate is effective in mice and rats in the maximal…
Pharmacologic Class:
Anti-epileptic Agent
Indications (2)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.