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FDA Staff: NPS Pharmaceuticals, Inc. (NPSP)'s Bowel Drug Needs No Safety Restrictions


10/12/2012 8:21:46 AM

U.S. drug reviewers found three serious concerns related to NPS Pharmaceuticals Inc's experimental drug for short bowel syndrome, but said they did not think the drug needed to be restricted for safety reasons, according to documents posted by the Food and Drug Administration on its website Friday. NPS shares were up 13 percent at $10.30 on Friday morning on the Nasdaq. The three risks observed by the FDA staff are gastrointestinal obstruction, biliary and pancreatic disorders and an acceleration in the growth of new tissue and colon polyps. link.reuters.com/nuq33t The staff said that the drug's approval would warrant a risk evaluation and mitigation strategy and supported the plans proposed by the company. However, it added that access to Gattex should not be restricted and the drug did not require any further assessment to assure safe use as it would be prescribed by skilled physicians and specialists.

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