Digestive Care completes NDA submission for pancreatic drug

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.”