Glenmark Pharmaceuticals granted tentative approval by the US health regulator to sell Rufinamide, which is used to treat seizures caused by Lennox-Gastaut syndrome.
Lennox-Gastaut syndrome (LGS), or childhood epileptic encephalopathy, is a pediatric epilepsy syndrome characterized by multiple seizure types; mental retardation or regression; and abnormal findings on electroencephalography (EEG).The approval has been granted for the tablets in 200 mg and 400 mg strengths. Rufinamide is a therapeutic equivalent of Banzel tablets of Eisai.
Glenmark's current portfolio consists of 96 products authorised for distribution in the US marketplace and 68 ANDAs (Abbreviated New Drug Application) pending approval with the FDA.
