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Drug Development
U.S. FDA issues approvable letter for Entereg (alvimopan)
August 26th, 2005
Adolor Corporation (ADLR) and GlaxoSmithKline (GSK) announced that Adolor has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Entereg (alvimopan) capsules, an investigational drug under review for the management of postoperative ileus (POI) by acceleration of the time to recovery of gastrointestinal (GI) function following bowel resection surgery. The new drug application (NDA) for Entereg was submitted in June 2004. Before the application may be approved, it will be necessary to provide additional proof of efficacy to the FDA to support the use of Entereg following bowel resection surgery. The FDA indicated that...
Source: Drug Week (2005-08-26)
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