FDA Approves Pancreatic Enzyme Products to Aid Digestion

02 Mar 2012 --- 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.

Mar 2 2012 --- Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved 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 needed 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.

Ultresa and Viokace are marketed by Bridgewater, N.J.-based Aptalis Pharma U.S. Inc.
 

Related Articles

Food Research

Study: Oat Oil Preparation Makes You Feel Fuller

21 Nov 2014 --- Oats contain more fat than other cereals, and oat oil has a unique composition. A new study from Lund University, Härröd Research and Swedish Oat Fiber AB, shows a special oat oil preparation can produce greater satiety.

Health & Nutrition News

Pope Francis Urges Solidarity and Concrete Action in Global Nutrition Challenge

21 Nov 2014 --- Pope Francis has told politicians from around the world to view food and nutrition and the environment as global public issues at a time when nations are more tightly linked with each other than ever before. "When solidarity is lacking in one country, it's felt around the world," he said.

Regulatory News

WHO: Over 170 Countries Make Commitments to Combat Malnutrition

20 Nov 2014 --- In a major step towards eradicating malnutrition worldwide, over 170 countries today made a number of concrete commitments and adopted a series of recommendations on policies and investments aimed at ensuring that all people have access to healthier and more sustainable diets.

Health & Nutrition News

CSPI Urges Dietary Guidelines Committee to Recommend Pregnant Women Avoid Caffeine, Coffee

20 Nov 2014 --- The federal government may be poised to give women who are or might become pregnant bad advice on how much caffeine is safe to consume during pregnancy, according to the Center for Science in the Public Interest. Draft advice from the government's Dietary Guidelines Advisory Committee indicates that pregnant women should be sure to limit their caffeine consumption to 200 milligrams per day.

More Articles
URL : http://www.nutritioninsight.com:80/news/FDA-Approves-Pancreatic-Enzyme-Products-to-Aid-Digestion.html