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

Nutrition & Health News

Diets rich in fish and vegetable oils could reduce epileptic seizures

18 Aug 2017 --- For the first time, production of estrogen in the brain has been directly linked to a study to the presence of docosahexaenoic acid (DHA). The findings of a Hiroshima University study could have implications for treating seizures, as it links DHA directly to a reduction in epileptic seizures.

Nutrition & Health News

Kyowa Hakko’s citicoline supplementation may slow glaucoma

18 Aug 2017 --- A 500mg dose of citicoline from Kyowa Hakko Europe (Kyowa) may significantly slow the progression of visual acuity loss due to glaucoma. This is according to a new study by researchers at the Sao Paolo Hospital Eye Clinic at the University of Milan, who followed 41 patients with progressing glaucoma – a disease that damages the optic nerve and can lead to vision problems and blindness – over two years.

Business News

DuPont expands US probiotics pilot facility to improve NPD, delivery times

18 Aug 2017 --- DuPont Nutrition & Health (DuPont) has announced a “substantial upgrade” to its probiotics pilot facility in Madison, Wisconsin, US. The new enhancements will increase its capability for rapidly developing and commercializing new probiotics with decreased time to market. The US$10 million investment allows for increased pace of new product development and significantly improved delivery times on pilot material for clinical trials and customer evaluations, according to DuPont.

Regulatory News

Cutting calories now “critical” to UK childhood obesity strategy

18 Aug 2017 --- The health agency Public Health England (PHE) has shifted its focus away from solely targeting sugar to cutting excess calorie consumption from all sources in its anti-obesity strategy for children in the UK. “A third of children leave primary school overweight or obese and an excess of calories – not just excess sugar consumption – is the root cause of this,” says Duncan Selbie, Chief Executive of PHE. “We will work with the food companies and retailers to tackle this as the next critical step in combating our childhood obesity problem.”

Nutrition & Health News

Walnuts activate brain area that controls appetite, finds study

17 Aug 2017 --- Consuming walnuts activates an area in the brain associated with regulating hunger and cravings. This is according to a first-of-its-kind new brain imaging study by researchers at Beth Israel Deaconess Medical Center (BIDMC), the findings of which, published online in the journal Diabetes, Obesity and Metabolism, reveal for the first time the neurocognitive impact the nuts have on the brain. 

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