The Food and Drug Administration (FDA) has withdrawn their approval of a New Drug Application (NDA) for Elepsia XR (levetiracetam; Sun Pharma) extended-release tablets due to regulatory issues at the manufacturing plant.
Sun Pharma had received FDA approval for Elepsia XR in March 2015 but has now received a Complete Response Letter (CRL) rescinding the earlier approval. The Letter states that the compliance status of the manufacturing facility was not acceptable on the date of approval; Sun Pharma is working with the FDA to resolve the manufacturing issues.
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. It was approved for adjunctive therapy in the treatment of partial onset seizures in patients ≥12 years old with epilepsy.
For more information visit FDA.gov.