October 30, 2008
Digestive Care Completes NDA Submission for Pancreatic Drug
US-based pharmaceutical company Digestive Care has completed the submission of the new drug application for Pancrecarb, used in the treatment of exocrine pancreatic insufficiency, to the FDA.
The FDA has previously granted the product fast track designation and approved a rolling new drug application (NDA) submission schedule.
The company has recently announced results of the completed randomized, double-blind, placebo-controlled, multi-center, crossover study on Pancrecarb.
Tibor Sipos, president and chief scientific officer of Digestive Care, said: "Pancrecarb is a unique bicarbonate buffered enteric-coated formulation of pancrelipase that has been an essential component of the armamentarium for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and other diseases affecting the pancreas."