Two New Pancreatic Enzyme Products From Aptalis Pharma Receive FDA Approval

The Food and Drug Administration March 1 announced the approval of two new pancreatic enzyme products used to help aid food digestion.

The products are Ultresa (pancrelipase) and Viokace (pancrelipase), both of which are marketed by Bridgewater, N.J.-based Aptalis Pharma U.S. Inc.

FDA said that Ultresa is a delayed-release capsule used to treat children and adults with cystic fibrosis, a serious genetic disorder affecting the lungs and other organs, or other conditions who cannot digest food normally because their pancreas does not make enough pancreatic enzymes.

The agency said that Viokace, in combination with a proton pump inhibitor, is used ...