BETHLEHEM, Pa., July 7 /PRNewswire/ -- Digestive Care, Inc. (DCI) announced today that it has submitted the first module of its New Drug Application ("NDA") for PANCRECARB(R) (pancrelipase), used in the treatment of Exocrine Pancreatic Insufficiency ("EPI"), with the U.S. Food and Drug Administration ("FDA"). The FDA has granted the product Fast Track designation.
"Digestive Care has provided vital products used to treat EPI for over a decade and we are committed to filing the remaining modules for the NDA for PANCRECARB(R) to meet the April 28, 2009 requirements set forth by the FDA," said Dr. Tibor Sipos, President and Chief Scientific Officer. "Digestive Care is committed to improving the quality of life for individuals suffering from chronic illnesses such as Cystic Fibrosis," added Dr. Sipos.
In addition, Digestive Care recently completed a randomized, double-blind, placebo-controlled, multi-center, crossover study on PANCRECARB(R) MS-16. The clinical trial was conducted at 5 centers and included 21 subjects. The results will soon be published at upcoming scientific meetings.
PANCRECARB(R) is a pancreatic enzyme replacement therapy for the treatment of Exocrine Pancreatic Insufficiency. It is the only enteric coated, bicarbonate buffered pancreatic enzyme available on the market today, and several U.S. patents protect PANCRECARB(R). In April 2004, the FDA determined that prescription Exocrine Pancreatic Insufficiency drug products are medically necessary and, accordingly, allowed the drug manufacturers four years (April 2008) to obtain approved new drug applications. The FDA then announced the deadline extension for unapproved pancreatic enzyme drug products to April 28, 2010, but only if the manufacturers have investigational new drug applications on active status on or before April 28, 2008 and have submitted NDAs on or before April 28, 2009. PANCRECARB(R) is on track to fulfill these requirements.'/>"/>
|SOURCE Digestive Care, Inc.|
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