Eurand N.V. received FDA approval for its NDA for Zenpep Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions. Zenpep is the only pancreatic enzyme product (PEP) approved for both adults and children, offered in four dosage strengths.

EPI is the inability to properly digest food due to a lack of digestive enzymes made by the pancreas. Loss of digestive enzymes leads to maldigestion and malabsorption of nutrients. Zenpep replaces these missing enzymes and improves digestion and absorption. The U.S. commercial launch of Zenpep is planned for 4Q09.

“For years, patients with EPI taking unapproved PEPs have lived with far too much variability in the control of their gastrointestinal symptoms as a result of product instability and dosing inconsistency,” said Gearid Faherty, chairman and chief executive officer. “The approval of Zenpep is a major milestone for patients suffering from EPI and for Eurand. In preparation for our U.S. launch we have built and continue to expand a first-rate commercial organization to help Zenpep reach its full market potential.”

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