FDA Approves Two New Pancreatic Enzyme Products

The FDA announced on Thursday that it has approved two pancreatic enzyme products (Ultresa and Viokace) for aiding food digestion in patients with pancreatic insufficiency. The active ingredient of both drugs is pancrelipase, a mixture of three digestive enzymes (amylase, lipase, and protease) normally produced by the pancreas.

Ultresa, a delayed-release capsule, is indicated for adults and children with pancreatic insufficiency due to cystic fibrosis or other conditions. Viokace, taken with a proton-pump inhibitor, is for adults who have undergone pancreatectomy or have chronic pancreatitis.

Because of problems with dose variations in unapproved products, the FDA previously mandated that all pancreatic enzyme products need to receive agency approval or be taken off the market.