Regulatory Actions
FDA Extends Review of NDA for ENTEREG(R) (alvimopan)
Published in Medical Letter on the CDC and FDA, March 2nd, 2008
The NDA for ENTEREG 12 mg capsules is for in-hospital, short-term use for the management of postoperative ileus (POI). Specifically, the proposed indication is for the acceleration of upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with...
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