XenoPort and Glaxo says FDA review of neuropathic pain drug extended 3 months
XenoPort 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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The U.S. Food and Drug Administration has given the approval to
The U.S. Food and Drug Administration has cleared US Spine’s Preference 2 Complex Spine System™ for use in the United States. With this approval,
The U.S. Food and Drug Administration has approved