Entereg FDA Approval History
FDA Approved: Yes (First approved May 20, 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 timeline for Entereg
| Date | Article |
|---|
| May 21, 2008 | Approval Adolor and GlaxoSmithKline Announce FDA Approval of Entereg
(alvimopan) for the Management of Postoperative Ileus (POI) |
| May 9, 2008 | Adolor Provides Regulatory Update on Entereg (alvimopan) |
| Feb 11, 2008 | FDA Extends Review of NDA for Entereg (alvimopan) |
| Jan 24, 2008 | Adolor and GlaxoSmithKline Report Favorable FDA Advisory CommitteeMeeting for Entereg (alvimopan) for the Management of PostoperativeIleus in Bowel Resection |
| Jan 18, 2008 | Adolor Announces Availability of Briefing Documents For January23rd FDA Advisory Committee Meeting on Entereg (alvimopan) |
| Nov 28, 2007 | Adolor and GlaxoSmithKline Announce FDA Advisory Committee toReview Entereg (alvimopan) for the Management of PostoperativeIleus (POI) |
| Aug 28, 2007 | FDA Accepts for Review Complete Response to Approvable Letter forEntereg (alvimopan) for POI |
| Jun 11, 2007 | GSK and Adolor Update Alvimopan (Entereg/Entrareg) DevelopmentProgram |
| Nov 6, 2006 | FDA Issues Approvable Letter for Entereg (alvimopan) for POI |
| May 31, 2006 | Adolor’s Complete Response to Approvable Letter Accepted for Review by FDA |
| Jul 22, 2005 | Adolor Receives FDA Approvable Letter for Entereg |
| Jan 10, 2005 | Adolor Announces FDA Update |
| Sep 8, 2004 | FDA Accepts Entereg for Review |
| Jun 28, 2004 | Adolor Completes Submission of NDA for Entereg |
| Jun 1, 2004 | Adolor Submits Second Portion of NDA for Entereg |
| May 7, 2004 | Adolor Submits First Portion of NDA for Entereg |
Further information
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