Neurology Product Guide » gabapentin enacarbil http://www.neurologyproductguide.com/blog A comprehensive guide to neurology products for medical professionals Tue, 27 Jul 2010 08:29:25 +0000 http://wordpress.org/?v=2.8.2 en hourly 1 XenoPort and Glaxo says FDA review of neuropathic pain drug extended 3 months http://www.neurologyproductguide.com/blog/2009/12/16/xenoport-and-glaxo-says-fda-review-of-neuropathic-pain-drug-extended-3-months/ http://www.neurologyproductguide.com/blog/2009/12/16/xenoport-and-glaxo-says-fda-review-of-neuropathic-pain-drug-extended-3-months/#comments Wed, 16 Dec 2009 11:36:47 +0000 Jim Marino http://www.neurologyproductguide.com/blog/?p=189 XenoPortXenoPort Inc. and GlaxoSmithKline PLC have said that the FDA needs three more months to review an application to a neuropathic pain drug being developed by them. The FDA should complete its review of the drug, called gabapentin enacarbil, by Feb. 9, 2010 said the companies. The FDA wanted the companies to develop a strategy to evaluate the drug’s risks, and after GlaxoSmithKline submitted that strategy, the agency needed additional time to review it.

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