Ultresa and Viokace Pancreatic-Enzyme Products Approved
THURSDAY, March 1 -- 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 inhibiting medication to treat adults with pancreatitis -- a chronic inflammation of the pancreas. 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 4th and 5th to be approved for these conditions.
Both new drugs are produced by Aptalis Pharma US, based in Bridgewater, N.J.
Medline Plus has more about pancreatic diseases.
Posted: March 2012