FDA Approves Third Pancreatic Enzyme Product: Pancreaze Delayed-Release Capsules

The U.S. Food and Drug Administration (FDA) has approved PancreazeTM delayed-release capsules, a pancreatic enzyme replacement therapy. This is the third such product to receive approval. Pancreaze is manufactured by Johnson & Johnson.

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More than 90 percent of people with cystic fibrosis take pancreatic enzyme replacements to help the body absorb essential vitamins and nutrients.

Previously, the FDA approved Creon®, manufactured by Abbott Products, Inc. (formerly Solvay Pharmaceuticals), and ZenpepTM, manufactured by Eurand Pharmaceuticals.

All pancreatic enzyme supplements are required to be approved by the FDA by April 28, 2010. Information is not available on the status of other enzymes awaiting FDA approval.

While pancreatic enzymes have been in use for decades, they are now undergoing a more rigorous review to help ensure that people with CF receive only the best and most effective enzyme treatments. The CF Foundation urged the FDA to do this review, which will help ensure that CF patients receive products that are documented to be both safe and effective.

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