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FDA delays Entereg action letter

13 May 2008

The US Food and Drug Administration has revealed that it has issued an action letter for Adolor's Entereg – a product that is designed to help manage postoperative ileus.

A report – Improving Postoperative Ileus – last year described the condition as a "transient impairment of bowel motility … usually considered an inevitable response to surgery".

Adolor is aiming to secure market approval from the FDA for the treatment as it claims that it can quicken recovery from large or small bowel resection surgery with primary anastomosis.

The date of the action letter was initially May 10th. However, the FDA has not provided a replacement date and instead informed Adolor that a decision on the status of the product will be made soon.

In related FDA news, last month the administration approved Pozen's migraine treatment Treximet. The decision follows two failed attempts to get the drug approved after the FDA had safety concerns, reports bizjournals.com.

Both Entereg and Treximet were developed in association with pharmaceuticals firm GlaxoSmithKline.

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