Eurand Addresses Questions Regarding Zentase NDA

Eurand is expecting FDA action late in the second quarter on its investigational pancreatic enzyme product Zentase after the agency accepted its raw material supplier’s response to questions about an NDA.

The company received an approvable letter for Zentase (pancrealipase) last June. Eurand submitted its response two months later, answering chemistry, manufacturing and control questions about the file. Eurand’s supplier submitted its response to questions from the FDA regarding its drug master file last December, the company says in a statement.

Zentase is a highly stable formulation of a porcine pancreatic extract that has eight key enzymes and multiple coenzymes and cofactors that are biologically similar to endogenous human pancreatic secretions, Eurand says. The company is seeking approval of the product to treat exocrine pancreatic insufficiency.
Drug GMP Report