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Adolor Corporation
Adolor Provides Regulatory Update on Entereg alvimopan
May 30th, 2008
Adolor Corporation (Nasdaq:ADLR) announced that the U.S. Food and Drug Administration (FDA) has communicated to the company that it will not be issuing an action letter on the NDA for Entereg(R) (alvimopan) for postoperative ileus by May 10, 2008, the scheduled PDUFA date. The FDA did not provide a specific date, but informed the company that it expects to issue the action letter shortly. Adolor is seeking marketing approval of Entereg for the proposed indication to accelerate upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. Keywords: Regulatory Actions, Adolor...
Source: Health Business Week (2008-05-30)
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