Date Published: 1 March 2012

FDA approves two new pancreatic enzyme products, Ultresa (pancrelipase) and Viokace (pancrelipase), to aid food digestion

Health News from the United States of America (USA)

Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), have recently been approved today by the U.S. Food and Drug Administration.

Ultresa is a delayed-release capsule used to treat children and adults with cystic fibrosis, a serious genetic disorder affecting the lungs and other organs, or other conditions who cannot digest food normally because their pancreas does not make enough pancreatic enzymes.

Viokace, in combination with a proton pump inhibitor, is used to treat adults who cannot digest food normally. Adults with chronic pancreatitis, a continuing, chronic inflammatory process of the pancreas, or those who have had some or all of their pancreases removed (pancreatectomy) may not digest food normally because they lack the necessary enzymes or because their enzymes are not released into the bowel (intestine). Viokace's safety and efficacy in children has not been established.

" The approvals of Ultresa and Viokace, along with the other approved pancreatic enzyme products, allow health care providers to prescribe the product that is most appropriate for the estimated 200,000 patients in the United States who have pancreatic insufficiency," said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA's Center for Drug Evaluation and Research.

 

Ultresa and Viokace are the fourth and fifth pancreatic enzyme products approved by FDA. Other FDA-approved pancreatic enzyme products include Creon (2009), Zenpep (2009) and Pancreaze (2010). Approved pancreatic enzyme products meet FDA standards for safety, efficacy and product quality.

Unapproved pancreatic enzyme products had been available for many years. FDA established a date of April 28, 2010 for the makers of pancreatic enzyme products to stop manufacturing and distributing unapproved products.


News is included on the IvyRose website to inform visitors about current health and related issues, but not to endorse any particular view or activity. Any views expressed in the article above are not necessarily those of IvyRose Ltd.. Material in this news item was released by the United States (U.S.) Food and Drug Administration (FDA) on 01 March 2011 . It may have been edited (e.g. in style, length, and/or for ease of understanding by our international readers) for inclusion here. For further information, please visit their website.

Source: The U.S. Food and Drug Administration
http://www.fda.gov -

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