Drug Information Update: FDA Approves Pancreatic Enzyme Product, Pancreaze

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Title: Drug Information Update: FDA Approves Pancreatic Enzyme Product, Pancreaze

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


The U.S. Food and Drug Administration today approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). It is the third such product to receive FDA approval.

Pancreatic enzyme products improve food digestion in patients whose bodies do not produce enough pancreatic enzymes. This includes people who have conditions such as cystic fibrosis, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas.

Until today, Creon, manufactured by Abbott Products, Inc. (formerly Solvay Pharmaceuticals), and Zenpep, manufactured by Eurand Pharmaceuticals, were the only FDA-approved pancreatic enzyme products on the market.

For more information, please visit:  Pancreatic Enzyme Product, Pancreaze

 


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