1 September 2014 – UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Vimpat (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. This is a new indication for Vimpat which is already approved in the U.S. as adjunctive treatment for partial-onset seizures in patients in this age group. This new indication means that adults with partial-onset seizures can be initiated on Vimpat monotherapy, and patients already on an anti-epileptic drug can be converted to Vimpat monotherapy.
UCB also announced today that the FDA has approved a new single loading dose administration option for all formulations of Vimpat, when used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.
For more details, go to: http://www.ucb.presscentre.com/News/New-indication-for-VIMPAT-lacosamide-UCB-s-anti-epileptic-drug-approved-by-FDA-as-monotherapy-in-4a0.aspx