Monday, August 13, 2012

FDA extends review time for NPS Pharma's bowel drug by three months

(Reuters) - NPS Pharmaceuticals Inc said U.S. health regulators pushed back the review date for the marketing approval application for its experimental bowel drug by three months. U.S. Food and Drug Administration will now decide on the approval of Gattex on December 30, 2012, the drugmaker said in a statement. The FDA extended the date to provide time for a full review of the submission, NPS Pharmaceuticals said. The application was accepted by the agency in January 2012. ... Original Source

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