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Pancrecarb MS-16 News

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

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Chronic Pancreatitis, Pancreatic Exocrine Dysfunction, Cystic Fibrosis

Pancrecarb MS-16 Patient Information at Drugs.com