GSK, XenoPort Provide FDA Answer to Complete Response on Horizant

The FDA has accepted GlaxoSmithKline (GSK) and XenoPort’s answer to a complete response letter on the companies’ NDA for the restless legs syndrome drug Horizant. The drug will have a new user fee action goal date of April 6, 2011, XenoPort said. The FDA had originally turned down the NDA for Horizant (gabapentin enacarbil) in February, citing a study finding of pancreatic tumors in rats.
Washington Drug Letter