Glaxo, XenoPort Drug To Get Longer FDA Review

NEW YORK (AP) — GlaxoSmithKline and XenoPort Inc. said Tuesday the Food and Drug Administration extended the review date of the company's potential restless leg syndrome treatment to Feb. 9.

The companies had originally expected the FDA to complete its review of GSK1838262, also called XP13512, by Nov. 9. The FDA had determined that the company needs to submit a risk evaluation and mitigation strategy. The agency now needs more time to review that plan.

XenoPort is based in Santa Clara, Calif., and GlaxoSmithKline is headquartered in London. ...