Wednesday, November 11, 2009
AMA Morning Rounds: FDA extends review of neuropathic pain drug
The AP (11/10) reports that the FDA "needs three more months to review an application to a neuropathic pain drug being developed by XenoPort Inc. and GlaxoSmithKline PLC," called gabapentin enacarbil, according to the companies. The companies said the FDA "should complete its review of the drug" by Feb. 9, 2010. The AP adds, "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." The Triangle Business Journal (11/9) also covered the story.
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