Health :: FDA issues approvable letter for Entereg for POI
GlaxoSmithKline (NYSE: GSK) and Adolor Corporation (Nasdaq: ADLR) announced that the Food and Drug Administration (FDA) has issued a letter stating that the new drug application (NDA) for Entereg (alvimopan 12mg) for the management of post operative ileus (POI) is approvable. The FDA has requested 12-month safety data, including analysis of serious cardiovascular events, from study 014 (767905/014), an ongoing safety study in opioid-induced bowel dysfunction (OBD). The FDA also requested a risk management plan as part of the submission.