July 8, 2008
Digestive Care Files First Module of NDA for Pancreatic Drug
Digestive Care has submitted the first module of its new drug application for Pancrecarb, used in the treatment of exocrine pancreatic insufficiency, with the FDA. The FDA has granted the product fast track designation.
In addition, Digestive Care has recently completed a randomized, double-blind, placebo-controlled, multi-center, crossover study on Pancrecarb MS-16. The clinical trial was conducted at five centers and included 21 subjects.Tibor Sipos, president and chief scientific officer of Digestive Care, said: "Digestive Care has provided vital products used to treat exocrine pancreatic insufficiency for over a decade and we are committed to filing the remaining modules for the new drug application (NDA) for Pancrecarb to meet the April 28, 2009 requirements set forth by the FDA."