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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.

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