Gastrointestinal Drugs Advisory Committee

Gastrointestinal Drugs Advisory Committee

Committee Meeting on January 12, 2011, from 8 a.m. to 5:00 p.m.

Agenda: On January 12, 2011, the committee will discuss the safety and efficacy of new drug application (NDA)022–486, for Solpura (liprotamase) Capsules, by Alnara Pharmaceuticals, for the proposed indication (use) in the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy (surgical removal of all or part of the pancreas), or other conditions that may impair or limit function of the pancreas. The pancreas is an organ involved, in part, in the digestion of food through the use of specialized proteins called enzymes. Exocrine pancreatic insufficiency is a decreased ability to digest food due to deficient enzyme production by the pancreas.