FDA Approves Ultresa — Pancreatic Enzyme Therapy for People with CF

March 2, 2012

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.

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.

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