Skip to Content

Zenpep Approval History

Zenpep (pancrelipase) is a combination of porcine-derived lipases, proteases, and amylases indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.

Development History and FDA Approval Process for Zenpep

Aug 28, 2009Approval Eurand Granted FDA Approval for Zenpep
Jun 19, 2008Eurand Receives Approvable Letter From FDA for EUR-1008 (Zentase)
Feb 21, 2008Eurand Granted Priority Review for Zentase NDA
Dec 20, 2007Eurand Completes New Drug Application for Zentase
Jun 12, 2007Eurand Files NDA for Zentase for Exocrine Pancreatic Insufficiency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.