FDA extends Prescription Drug User Fee Act date for ezogabine

GlaxoSmithKlineAug 31 2010

GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International (NYSE: VRX) announced today the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for ezogabine to 30 November 2010.  The original goal date was 30 August 2010.

The FDA has not yet completed the review of the New Drug Application (NDA) for ezogabine due to the recent submission of a formal REMS (Risk Evaluation and Mitigation Strategy) for ezogabine, an investigational anti-epileptic drug being studied for the adjunctive treatment of adults with partial onset seizures. The REMS was requested by FDA in correspondence dated 16 August 2010 and submitted to the FDA on 26 August 2010.  

The NDA was submitted to the FDA on 30 October 2009.  The companies will continue to work closely with FDA as the Agency completes its review.