Wednesday, February 17, 2010

GlaxoSmithKline and XenoPort receive FDA Complete Response letter for Horizant™ (GSK1838262/XP13512) for RLS

GlaxoSmithKline and XenoPort, Inc. Wednesday received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Horizant™(gabapentin enacarbil) Extended-Release Tablets, an investigational non-dopaminergic treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).


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