Drug Development
FDA To Continue Its Review of Requests for Release of Clinical Hold on alvimopan (Entereg)
Published in Lab Business Week, September 30th, 2007
Adolor Corporation (Nasdaq:ADLR) announced that the U. S. Food and Drug Administration (FDA) has informed Adolor and GlaxoSmithKline (GSK) that it needs additional time to complete its review of the submissions for the release of the clinical hold on alvimopan (Entereg(R)), and as a result, the clinical hold for all alvimopan Investigational New Drug Applications (INDs) remains in effect. The FDA did not indicate a time frame within which its review would be completed. Adolor and GSK intend to continue working with the FDA while it considers the release of the clinical hold.
Regarding the New Drug Application (NDA) for alvimopan for the management of postoperative ileus...
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Source: Lab Business Week (2007-09-30)
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