FDA approves two new drugs for pancreatic disorders

Agency approves Aptalis Pharma's Ultresa, Viokase

SILVER SPRING, Md. — The Food and Drug Administration has approved two new drugs for pancreatic disorders, the agency said Thursday.

The FDA announced the approval of Aptalis Pharma's Ultresa and Viokase, both generically known as pancrelipase. Ultresa is a delayed-release capsule for children and adults with cystic fibrosis, which affects the lungs and other organs, while Viokase is meant for use with a proton-pump inhibitor in adults who can't digest food because of pancreatitis or surgical removal of the pancreas.

"The approvals of Ultresa and Viokase, along with the other approved pancreatic enzyme products, allow healthcare providers to prescribe the product that is most appropriate for the estimated 200,000 patients in the United States who have pancreatic insufficiency," Office of Drug Evaluation III director Julie Beitz said.


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