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 a
|SOURCE Digestive Care, Inc.|
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