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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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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