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

Business News

The Protein Challenge Debated at HiEurope

22 Dec 2014 --- During the recent Hi Europe & Ni Conference 2014 in Amsterdam, Suzane Leser, Volac’s Head of Nutrition posed the question: “how can we reach a sustainable supply and demand of protein that meets growing health needs?”

Food Research

A Change of Diet to Unmask Cancer Vulnerabilities and Reduce Cancer Risk

19 Dec 2014 --- Many recent studies showed that calorie restrictions reduce the incidence of cancer, whereas high-calorie diets cause obesity and diabetes, both of which increase the risk of developing cancers.

Food Research

Many Children and Adolescents Get Too Much Caffeine From Energy Drinks

19 Dec 2014 --- When children aged 10-14 consume energy drinks, one in five consumes too much caffeine. When their caffeine intake from other sources such as cola and chocolate is included, every second child and more than one in three adolescents aged 15-17 consume too much caffeine. This is the finding of a new study conducted by the National Food Institute, Technical University of Denmark. The institute estimates that energy drinks cause or contribute to a large proportion of children and adolescents exceeding the recommended maximum daily intake of caffeine.

Food Ingredients News

Rousselot Launches Powerful Ingredient for Protein Enrichment

18 Dec 2014 --- Rousselot, the world leader in gelatines and collagen peptides, highlighted ProTake-P, a hydrolysed gelatine boasting 90% protein content, at HiE this year. The new ingredient allows manufacturers of dairy goods, sports nutrition, snacks, bars and powder blends to develop new products to meet the unabated demand for protein-enriched foods and drinks, or to reformulate existing products.

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