Drugs
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Pancrelipase (marketed as Pancreaze, Creon and Zenpep) Information
FDA has approved pancrelipase for adult and pediatric patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), chronic pancreatitis, and other conditions.
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Related Information
Updated Questions and Answers for Healthcare Professionals and the Public: Use an Approved Pancreatic Enzyme Product (PEP)
5/24/2010FDA Approves Pancreatic Enzyme Product, Pancreaze
4/12/2010FDA Response to Creon Citizen Petition (PDF - 12.3MB)Questions and Answers: Delayed-Release Pancreatic Enzyme Product Receives FDA Approval
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Labeling and Regulatory History from Drugs@FDA
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