Horizant gabapentin enacarbil regulatory update

FDA accepted for review a response from GlaxoSmithKline to a February complete response letter for Horizant gabapentin enacarbil (XP13512, GSK1838262) extended-release tablets to treat moderate to severe primary restless legs syndrome (RLS). FDA designated the response as a Class 2 resubmission and set a PDUFA date of April 6, 2011 (see BioCentury, Feb. 22). ...