New Drugs Approved by FDA

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

Latest New Drug Approvals

Entereg (alvimopan) Capsules

Date of Approval: May 20, 2008

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.

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