FDA receives complete response for Entereg NDA

UK drug major GlaxoSmithKline and USA-based Adolor say that the Food and Drug Administration has accepted as complete the latter's response to the November 2006 New Drug Application "approvable" letter for Entereg (alvimopan) for the management of postoperative ileus. The FDA has set an action date of February 10, 2008.

Adolor and GSK have also submitted complete responses to the FDA requesting a release of the clinical holds for all alvimopan Investigational New Drug Applications. The complete responses were received by the Agency on August 13. A decision with regard to these requests is pending from the agency. A release of its clinical holds is required before the companies can re-initiate any clinical development activities.