GSK and Xenoport to withdraw and resubmit US NDA for Solzira in RLS
This article was originally published in Scrip
Executive Summary
GlaxoSmithKlineand Xenoporthave decided to withdraw and resubmit their NDA for approval of Solzira (gabapentin enacarbil) extended-release tablets, for the treatment of moderate to severe restless legs syndrome – which was filed with the US FDA in September (Scrip Online, September 18th, 2008).