Ultresa and Viokace approved by the FDA


The U.S. Food and Drug Administration (FDA) have approved two new products to assist in ensuring the adequate supply of medications used to help aid food digestion.

The FDA officially approved pancreatic enzyme products Ultresa (pancrelipase) and Viokace (pancrelipase) in an announcement on March 1.

Ultresa is described as a “delayed-release capsule used to treat children and adults with cystic fibrosis” or other conditions which inhibit the afflicted individual from being able to digest food normally because their pancreas does not make enough pancreatic enzymes.

Comparatively, Viokace is used “in combination with a proton pump inhibitor to treat adults who cannot digest food normally.” Examples of adults with conditions that may call for this treatment would be chronic pancreatitis, or those who have had some or all of their pancreases removed (pancreatectomy) and may not digest food normally because they lack needed enzymes or because their enzymes are not released into the bowel (intestine). It’s important to note, however, that Viokace’s safety and efficacy has not been established yet for children.

These two medications are the fourth and fifth pancreatic enzyme products to be approved by the FDA. The other three approved medications for treating these forms of illnesses are Creon, Zenpep, and Pancreaze, which were each approved between 2009-2010.

For updated questions and answers from the FDA regarding these approved pancreatic enzyme products, visit fda.gov.


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