Two pancreatic-enzyme products approved
(HealthDay) -- Two drugs that supplement the digestion-aiding actions of pancreatic enzymes have been approved by the U.S. Food and Drug Administration, the agency said Thursday in a news release.
Ultresa (pancrelipase) was 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.
The second drug, Viokace (pancrelipase), is to be used in combination with a proton pump inhibitor to treat adults with pancreatitis. This drug's safety and effectiveness have not been established in children, the agency said.
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.
Both new drugs are produced by Aptalis Pharma US, based in Bridgewater, N.J.
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