BETHLEHEM, Pa., Oct. 27 /PRNewswire/ -- Digestive Care, Inc. (DCI) announced today that it has completed the submission of the New Drug Application ("NDA") for PANCRECARB(R) (pancrelipase), used in the treatment of Exocrine Pancreatic Insufficiency ("EPI"), to the U.S. Food and Drug Administration ("FDA"). The FDA had previously granted the product Fast Track designation and approved a rolling NDA submission schedule.
"Digestive Care has provided vital products used to improve the nutritional status of patients living with chronic diseases, such as cystic fibrosis, for over a decade. We are excited about the results of our Clinical Trials submitted with the PANCRECARB(R) NDA, and are pleased to have completed the NDA submission prior to the April 28, 2009 deadline set forth by the FDA," said Dr. Tibor Sipos, President and Chief Scientific Officer. "PANCRECARB(R) is a unique bicarbonate buffered enteric-coated formulation of pancrelipase that has been an essential component of the armamentarium for the treatment of EPI associated with cystic fibrosis (CF) and other diseases affecting the pancreas. We are dedicated to continuing to provide PANCRECARB(R) to CF patients and others suffering from EPI," added Dr. Sipos.
The results of the recently completed randomized, double-blind, placebo-controlled, multi-center, crossover study on PANCRECARB(R) MS-16 was presented at the 2008 North American Cystic Fibrosis Conference, October 23-25 in Orlando, Florida.
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.
About Digestive Care, Inc.
DCI is a privately held fully integrated pharmaceutical company dedicated to developing unique pharmaceutical products to alleviate complications and symptoms of gastrointestinal disorders. DCI was founded in 1990. The company holds 15 U.S. and foreign patents and has a national distribution network. The technology of DCI is based on the ability to commercially develop unique drug delivery systems for delivering bioactive molecules to their target site. The company has grown from an initial research based organization to a fully integrated pharmaceutical company encompassing Research, Product Development, Manufacturing, Packaging, Distribution, Marketing, and Sales. DCI's research into the controlled delivery of gastric acid resistant digestive enzymes and buffered bile acids through micro encapsulation led to the development of the successful drug product, PANCRECARB(R) (pancrelipase) which is manufactured in the USA. For information, please visit us at http://www.digestivecare.com.
|SOURCE Digestive Care, Inc.|
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