GSK, Valeant respond to CRL for ezogabine

LONDON — GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

GSK and Valeant said that their new drug application for ezogabine, an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial-onset seizures, was not approved by the FDA, and said they received the CRL on Nov. 30, 2010. Last August, the FDA announced it pushed back its review of ezogabine after a formal risk evaluation and mitigation strategy was submitted to the agency from GSK and Valeant, per its request.

The FDA issues a CRL when it has finished reviewing the application for a drug but issues remain that preclude final approval.