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.

April 15, 2010 | 1 min read

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.

Additional Resource

Share this article
Recent news
Cystic Fibrosis Community Perspectives Influence Future of CF Care Model
News | 4 min read
CF Foundation Adapts Registry Reporting to New Race-Neutral Standards
News | 5 min read
Nearly 350 Advocates Urge Congressional Action During 17th Annual March on the Hill
News | 3 min read
Stay up to date with The Foundation

Sign up for our newsletter to get all of the latest news from The Foundation right in your inbox.