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Entereg Approval History

  • FDA approved: Yes (First approved May 20th, 2008)
  • Brand name: Entereg
  • Generic name: alvimopan
  • Dosage form: Capsules
  • Company: Adolor Corporation
  • Treatment for: Postoperative Ileus

Entereg (alvimopan) is a peripherally-acting mu opioid receptor antagonist used to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery.

Development History and FDA Approval Process for Entereg

May 21, 2008Approval Adolor and GlaxoSmithKline Announce FDA Approval of Entereg (alvimopan) for the Management of Postoperative Ileus (POI)
May  9, 2008Adolor Provides Regulatory Update on Entereg (alvimopan)
Feb 11, 2008FDA Extends Review of NDA for Entereg (alvimopan)
Jan 24, 2008Adolor and GlaxoSmithKline Report Favorable FDA Advisory Committee Meeting for Entereg (alvimopan) for the Management of Postoperative Ileus in Bowel Resection
Jan 18, 2008Adolor Announces Availability of Briefing Documents For January 23rd FDA Advisory Committee Meeting on Entereg (alvimopan)
Nov 28, 2007Adolor and GlaxoSmithKline Announce FDA Advisory Committee to Review Entereg (alvimopan) for the Management of Postoperative Ileus (POI)
Aug 28, 2007FDA Accepts for Review Complete Response to Approvable Letter for Entereg (alvimopan) for POI
Jun 11, 2007GSK and Adolor Update Alvimopan (Entereg/Entrareg) Development Program
Nov  6, 2006FDA Issues Approvable Letter for Entereg (alvimopan) for POI
May 31, 2006Adolor’s Complete Response to Approvable Letter Accepted for Review by FDA
Jul 22, 2005Adolor Receives FDA Approvable Letter for Entereg
Jan 10, 2005Adolor Announces FDA Update
Sep  8, 2004FDA Accepts Entereg for Review
Jun 28, 2004Adolor Completes Submission of NDA for Entereg
Jun  1, 2004Adolor Submits Second Portion of NDA for Entereg
May  7, 2004Adolor Submits First Portion of NDA for Entereg

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