GlaxoSmithKline and Adolor's seemingly never-ending effort to win approval for Entereg has hit yet another delay. The FDA informed the companies that it would not make a decision by Saturday, the drug's PDUFA date. No date was given but the FDA said it would provide further details soon in an action letter.
GSK and Adolor have been attempting to gain FDA approval for Entereg since 2006, when the agency issued an approval letter and asked the companies for additional safety data. If approved, Entereg will be used to treat postoperative ileus in bowel resection.
- here's the release