BioCentury
ARTICLE | Clinical News

Ezogabine regulatory update

December 6, 2010 8:00 AM UTC

FDA issued a complete response letter to Valeant for an NDA for ezogabine as an adjunctive treatment for partial-onset seizures. According to Valeant and partner GlaxoSmithKline, FDA cited non-clinical reasons for the letter. The partners plan to respond as soon as possible in 2011. ...