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Pancreatic Exocrine Dysfunction News

Artificial Pancreas to Get Long-Term 'Real-Life' Trial

Posted 6 Jan 2016 by Drugs.com

TUESDAY, Jan. 5, 2016 – A long-term clinical trial of an artificial pancreas designed to control blood sugar levels in people with type 1 diabetes will begin early this year. The artificial pancreas will be tested for six months in 240 people with type 1 diabetes at nine sites in the United States and Europe. Researchers will compare this system to current diabetes management with an insulin pump. Then, 180 of those patients will be followed for another six months, the researchers said. The wearable system – developed by University of Virginia and Harvard University researchers with almost $13 million in funding from the U.S. National Institutes of Health – supplies appropriate amounts of insulin by detecting changes in the body and predicting blood sugar levels in advance. "The idea is that this can lead to an improved quality of life for individuals with this disease – not a ... Read more

Related support groups: Diabetes, Type 1, Pancreatic Exocrine Dysfunction, Diagnosis and Investigation, Pancreatic Secretion

Digestive Care, Inc. Announces FDA Approval of Pertzye (pancrelipase) Delayed-Release Capsules

Posted 18 May 2012 by Drugs.com

BETHLEHEM, Pa., May 18, 2012 /PRNewswire/ – Digestive Care, Inc. (DCI), announced that the company has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Pertzye, indicated for the treatment of Exocrine Pancreatic Insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. Pertzye is a unique pancreatic enzyme product containing bicarbonate-buffered enteric-coated microspheres and is protected by several U.S. and international patents.  The Pertzye formulation was previously marketed by DCI for over a decade under the trade name Pancrecarb MS-16. Dr. Tibor Sipos, President and Chief Scientific Officer at DCI stated, "The approval of Pertzye represents a significant milestone for DCI.  This achievement confirms our commitment to the continued development of products vital to the well-being of patients living with chronic diseases." T ... Read more

Related support groups: Cystic Fibrosis, Pancreatic Exocrine Dysfunction, Pancrelipase, Pancrecarb MS-16

Aptalis Pharma Announces FDA Approval of Viokace (Pancrelipase) Tablets

Posted 1 Mar 2012 by Drugs.com

BRIDGEWATER, NJ--(Marketwire - March 1, 2012) - Aptalis Pharma, a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis, announced that the U.S. Food and Drug Administration (FDA) has approved Viokace (pancrelipase) tablets. Viokace (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy. Important Prescribing Information for Viokace Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of Viokace exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day). Viokace is not interchangeable with any other pancrelipase product. Exercise caution when prescribing Viokace to patients with gout, renal impairment, or hyperuricemia. There is theoretical risk of ... Read more

Related support groups: Pancreatic Exocrine Dysfunction, Pancrelipase

Aptalis Pharma Announces FDA Approval of Ultresa (Pancrelipase) Delayed Release Capsules

Posted 1 Mar 2012 by Drugs.com

BRIDGEWATER, NJ--(Marketwire - March 1, 2012) - Aptalis Pharma, a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis, announced that the U.S. Food and Drug Administration (FDA) has approved Ultresa (pancrelipase) Delayed Release Capsules. Ultresa (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis (CF) or other conditions. Important Prescribing Information for Ultresa Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of Ultresa exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day). Ultresa is not interchangeable with any other pancrelipase product. To avoid irritation of oral mucosa, do not chew Ultresa or retain in mouth. Exercise caution when prescribing ... Read more

Related support groups: Pancreatic Exocrine Dysfunction, Pancrelipase

Ultresa and Viokace Pancreatic-Enzyme Products Approved

Posted 1 Mar 2012 by Drugs.com

THURSDAY, March 1 – Two drugs that supplement the digestion-aiding actions of pancreatic enzymes have been approved by the U.S. Food and Drug Administration, the agency said Thursday in a news release. Ultresa (pancrelipase) was approved for adults and children with cystic fibrosis and other disorders that affect food digestion because the pancreas does not produce enough enzymes, the FDA said. The second drug, Viokace (pancrelipase), is to be used in combination with a proton pump inhibiting medication to treat adults with pancreatitis – a chronic inflammation of the pancreas. This drug's safety and effectiveness have not been established in children, the agency said. About 200,000 people in the United States have "pancreatic insufficiency" disorders, according to the FDA. The two new medications are the 4th and 5th to be approved for these conditions. Both new drugs are produced by ... Read more

Related support groups: Pancreatic Exocrine Dysfunction, Pancrelipase

Abbott Receives FDA Approval for Creon (pancrelipase) Infant-Specific Dosage for Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Posted 14 Jun 2011 by Drugs.com

First infant-specific dosage strength now approved by the FDA ABBOTT PARK, Ill., June 14, 2011 /PRNewswire/ – Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved an infant-specific dose of Creon (pancrelipase) Delayed-Release Capsules to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The Creon 3,000 units of lipase capsule provides the lowest dosage strength in the class approved by the FDA. This new option will enable more precise dosing titration in accordance with the Cystic Fibrosis Foundation guidelines for infant dosing. Most infants with CF require small doses of pancreatic enzyme replacement therapy (PERT) with every feeding. Until now, parents or caregivers administering an infant dose of PERT have had to open a capsule of a larger dose and measure out a portion of the contents. The new 3,000 units of lipase capsule ... Read more

Related support groups: Creon, Pancreatic Exocrine Dysfunction, Creon 10, Creon 20, Creon 5

FDA Approves Pancreatic Enzyme Product, Pancreaze

Posted 13 Apr 2010 by Drugs.com

SILVER SPRING, Md., April 12 /PRNewswire-USNewswire/ – The U.S. Food and Drug Administration today approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). It is the third such product to receive FDA approval. Pancreatic enzyme products improve food digestion in patients whose bodies do not produce enough pancreatic enzymes. This includes people who have conditions such as cystic fibrosis, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas. Until today, Creon, manufactured by Abbott Products, Inc. (formerly Solvay Pharmaceuticals), and Zenpep, manufactured by Eurand Pharmaceuticals, were the only FDA-approved pancreatic enzyme products on the market. Today's approval of Pancreaze, manufactured by Johnson & Johnson, increases the supply of FDA-approved PEPs for the estimated 200,000 or more patients in the United States who need ... Read more

Related support groups: Pancreatic Exocrine Dysfunction, Pancrelipase

Eurand Granted FDA Approval for Zenpep

Posted 2 Dec 2009 by Drugs.com

PHILADELPHIA, PA, Aug 28, 2009 – Eurand N.V., a specialty pharmaceutical company, today announced U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Zenpep (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions. Zenpep is the only FDA-approved pancreatic enzyme product (PEP) that has been evaluated in clinical studies in adults and children – including children from one to 12 years old – and will offer four dosage strengths to meet the varied needs of infants, toddlers, adolescents and adults with EPI. "The availability of clinical evidence in a pediatric population is particularly important for EPI patients with CF and their caregivers, as early improvements in BMI (Body Mass Index) significantly affect long-term survivability," said Jamie ... Read more

Related support groups: Pancreatic Exocrine Dysfunction, Pancrelipase

Creon, a Pancreatic Enzyme Substitute, Approved

Posted 7 May 2009 by Drugs.com

THURSDAY, May 7 – Creon (pancrelipase), a pancreatic enzyme replacement for people with cystic fibrosis and other conditions that involve exocrine pancreatic insufficiency, has been approved by the U.S. Food and Drug Administration for adults and children. The drug is designed to help people with these conditions absorb dietary nutrients, including fats, proteins and sugars. Creon is made from a mixture of digestive enzymes extracted from the pancreas of pigs, the FDA said in a news release. While the agency acknowledged a "theoretical risk of contracting a viral infection from pig-derived medicines," it said no cases of human illness stemming from the drug had been reported. The maker of Creon, Solvay Pharmaceuticals, is required to submit both a risk evaluation assessment and medication guide, designed to advise users of the risks of pig-derived drugs, and about the risk of taking ... Read more

Related support groups: Cystic Fibrosis, Pancreatic Exocrine Dysfunction, Arco-Lase

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Creon, Zenpep, Pancrease, Pancreaze, Viokase, pancrelipase, Ultrase, Ultrase MT 20, Pancrease MT 20, view more... Ultrase MT 12, Cotazym, Panokase, Pancrease MT 4, Pancrease MT 10, Viokase 16, Viokase 8, Viokace, Panocaps, Pangestyme UL 20, Dygase, Pancrecarb MS-16, Lipram-CR5, Lipram-CR, Plaretase, Panocaps MT 16, Lapase, Lipram-PN16, Pertzye, Ultresa, Lipram UL, Pancrease MT, Ku-Zyme, Panokase 16, Palcaps 10, Lipram-PN10, Pancrecarb MS, Lipram-PN20, Lipram-CR10, Pancreatil-UL 12, Ilozyme, Vio-Moore, Pancron D / R, Encron-10, Ultrase MT 18, Protilase MT-16, Cotazym-S, Pancrease MT 16, Zymase, Protilase, Panase, Ku-Zyme HP, Arco-Lase, Lipram, Pangestyme CN 20, Pangestyme CN 10, Pangestyme MT 16, Pangestyme UL 18, Pangestyme EC, Lipram-UL 20, Lipram-UL 12, Pancrecarb MS-8, Pancrecarb MS-4, Lipram-UL 18, Lipram-CR20, Kutrase