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Entereg gets US approval

The US Food and Drug Administration (FDA) has approved Entereg, a medicine manufactured and developed by Adolor and GlaxoSmithKline (GSK).

The US Food and Drug Administration (FDA) has approved Entereg, a medicine manufactured and developed by Adolor and GlaxoSmithKline (GSK).

The medication has been developed to alleviate the symptoms of post-operative ileus (POI). Following extensive studies conducted into the drug's efficacy and safety, the FDA has approved it for use in patients to restore normal gastrointestinal function after undergoing bowel resection surgery. GSK has called Entereg an important new drug for the company that it can now offer to its hospital costumers.

"This approval of Entereg in POI represents a major milestone for Adolor, and is the culmination of a substantial collaborative effort amongst Adolor. GSK and our clinical investigators," said Michael Dougherty, president and chief executive officer of Adolor.

Entereg has been approved with a Risk Evaluation and Mitigation Strategy (REMS) that means limitations have been placed on dispensing of the drug.

Data collected during clinical testing showed that some patients given a twice-daily 0.5mg dose of Entereg experienced myocardial infarction. The FDA has said that it will monitor the product's performance throughout its life cycle.

21st May 2008

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