FDA issues CRL for Ezogabine NDA: GSK, Valeant Pharma

Ezogabine is an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial-onset seizures.

A CRL is issued by the FDA’s Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form.

GSK and Valeant are evaluating the Complete Response letter in which FDA cited non-clinical reasons for this action.

GSK and Valeant believe that these items can be addressed and the two companies are working for a timely response to the FDA as soon as possible in 2011.

The NDA was submitted to the FDA on 30 October 2009.