Two pancreatic-enzyme drugs approved
HealthDay News -- The FDA approved two drugs -- Ultresa and Viokace, both manufactured by Aptalis Pharma -- for patients with pancreatic enzyme deficiencies.
Ultresa and Viokace are different formulations of the pancreatic enzyme, pancrelipase. Both are intended to aid in digestion, but have different indications.
Ultresa, a delayed-release capsule, is approved for adults and children with cystic fibrosis and other disorders that affect food digestion because the pancreas does not produce enough enzymes, the FDA said in a press release.
Viokace (pancrelipase), is to be used in combination with a proton pump inhibitor to treat adults with pancreatitis who have undergone partial or total pancreatectomy. This drug's safety and effectiveness have not been established in children.
About 200,000 people in the United States have "pancreatic insufficiency" disorders, according to the FDA. The two new medications are the fourth and fifth to be approved for these conditions. They join Creon, Zenpep and Pancreaze, which were approved in 2009 and 2010.