GSK, Valeant respond to FDA CRL for antiepileptic drug
This article was originally published in Scrip
Executive Summary
London-based GlaxoSmithKline and its partner Mississauga, Ontario-based Valeant Pharmaceuticals submitted their response to the US FDA's 30 November 2010 complete response letter (CRL) for the firms' new drug application for ezogabine, an experimental antiepileptic drug under investigation as an adjunctive treatment for adults with partial-onset seizures. The drug is known as retigabine outside the US.