The Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Elepsia (XR (levetiracetam; Sun Pharma) extended-release tablets for adjunctive therapy in the treatment of partial onset seizures in patients ≥12 years old with epilepsy.

Elepsia XR is an extended-release formulation of levetiracetam, an antiepileptic. The precise mechanism by which levetiracetam exerts its antiepileptic effect is unknown. In vitro and in vivo recordings of epileptiform activity from the hippocampus have shown that levetiracetam inhibits burst firing without affecting normal neuronal excitability, suggesting that levetiracetam may selectively prevent hypersynchronization of epileptiform burst firing and propagation of seizure activity.

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Elepsia XR will be available as 1000mg and 1500mg strength tablets in 30-, 100-, and 500-count bottles.

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