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 the NDA. Eurand received an approvable letter for Zentase (pancrealipase) last June. It submitted its response in August 2008, answering chemistry, manufacturing and control questions about the file.
Drug GMP Report