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<blockquote data-quote="tD33NAt" data-source="post: 2087617" data-attributes="member: 124445">GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) 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).&nbsp;&nbsp; A Complete Response letter is issued by the FDA&#039;s Center of Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form...<a href="http://feedads.g.doubleclick.net/~a/oBdlbOhRbJ-501CqT_luBan4uVM/0/da" target="_blank"><img src="http://feedads.g.doubleclick.net/~a/oBdlbOhRbJ-501CqT_luBan4uVM/0/di" alt="" class="fr-fic fr-dii fr-draggable " data-size="" style="" /></a><a href="http://feedads.g.doubleclick.net/~a/oBdlbOhRbJ-501CqT_luBan4uVM/1/da" target="_blank"><img src="http://feedads.g.doubleclick.net/~a/oBdlbOhRbJ-501CqT_luBan4uVM/1/di" alt="" class="fr-fic fr-dii fr-draggable " data-size="" style="" /></a><img src="http://feeds.feedburner.com/~r/mnt/healthnews/~4/lofFbawfoB8" alt="" class="fr-fic fr-dii fr-draggable " data-size="" style="" /><a href="http://feedproxy.google.com/~r/mnt/healthnews/~3/lofFbawfoB8/3xV4" target="_blank">More...</a></blockquote>

[QUOTE="tD33NAt, post: 2087617, member: 124445"] GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) 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). A Complete Response letter is issued by the FDA's Center of Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form...[URL="http://feedads.g.doubleclick.net/~a/oBdlbOhRbJ-501CqT_luBan4uVM/0/da"][IMG]http://feedads.g.doubleclick.net/~a/oBdlbOhRbJ-501CqT_luBan4uVM/0/di[/IMG][/URL] [URL="http://feedads.g.doubleclick.net/~a/oBdlbOhRbJ-501CqT_luBan4uVM/1/da"][IMG]http://feedads.g.doubleclick.net/~a/oBdlbOhRbJ-501CqT_luBan4uVM/1/di[/IMG][/URL] [IMG]http://feeds.feedburner.com/~r/mnt/healthnews/~4/lofFbawfoB8[/IMG] [url=http://feedproxy.google.com/~r/mnt/healthnews/~3/lofFbawfoB8/3xV4]More...[/url] [/QUOTE]

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