Entereg accepted for review by FDA
USA-based biopharmaceutical company Adolor and UK drug major GlaxoSmithKline say that the US Food and Drug Administration has accepted Adolor's response to an approvable letter that the agency issued in July 2005 relating to the co-developed drug Entereg (alvimopan).
The drug, which is intended for use in the management of post-operative ileus, originally received the approvable letter on the condition that additional efficacy data were provided. The firm's subsequent trial work met with these requirements, and has been accepted by the agency.
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