FDA Approves Eurand’s Zenpep

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.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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...

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