NEW YORK (AP) – The Food and Drug Administration needs three more months to review an application to a neuropathic pain drug being developed by XenoPort Inc. and GlaxoSmithKline PLC, the companies said.
XenoPort and GlaxoSmithKline said the FDA should complete its review of the drug, called gabapentin enacarbil, by Feb. 9, 2010. The review period was scheduled to end November 9th. 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.
XenoPort is based in Santa Clara, Calif., and GlaxoSmithKline is headquartered in London. In premarket trading, XenoPort stock rose 7 cents to $18.21 from $18.14.
Date: November 9, 2009
Source: Associated Press
Filed Under: Drug Discovery