CMPH gives nod to UCB's Keppa for EU appro

Belgian drugmaker UCB says that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA) has recommended marketing authorization for intravenous Keppra (levetiracetam) concentrate (100 mg/mL) for use as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adults and children of four years of age and older with epilepsy.

The firm also received an approvable letter from the US Food and Drug Administration in response to its New Drug Application for Keppra Injection 100 mg/mL for use as adjunctive therapy in the treatment of partial-onset seizures in adult patients with epilepsy.