FDA Approves Ultresa — Pancreatic Enzyme Therapy for People with CF

The U.S. Food and Drug Administration (FDA) announced that it has approved Ultresa™ delayed-release capsules, a pancreatic enzyme replacement therapy. Ultresa (pancrelipase) is manufactured by Aptalis Pharma.

| 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.

This is the fourth such product to receive FDA approval. Previously, the FDA approved Creon® (Abbott Products Inc.), Zenpep™ (Aptalis) and Pancreaze® (Johnson & Johnson).

While pancreatic enzymes have been in use for decades, in 2004 the FDA required that all pancreatic enzyme products on the market undergo 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 to help ensure that people with CF receive products that are documented to be both safe and effective.

Additional Resource

Share this article
Topics
About the CF Foundation | Drug Pipeline | Medications
Recent news
CF Foundation Awards $1.6 Million to Improve Detection of Lung Transplant Complication
News | 5 min read
CF Foundation Announces New National Advocacy Chairs
News | 5 min read
More Than 160 Advocates Raise Their Voices for PASTEUR Act During 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.

Subscribe