GSK submits FDA request for approval for restless leg syndrome drug
LONDON GlaxoSmithKline has resubmitted an approval application to the Food and Drug Administration requesting approval of a drug for restless leg syndrome.
GSK announced Friday that it had submitted its application for Solzira (gadapentin enacarbil), a drug that it developed with United States biotech company XenoPort, after the FDA requested a reformat of the data in one of the studies used to support the application.