FDA approves 2 drugs for rare digestive disorders

WASHINGTON (AP) The Food and Drug Administration said Thursday it approved two new drugs to aid food digestion in children and adults with rare diseases.

The agency approved two pill-based drugs containing the ingredient pancrelipase, which mimics pancreatic enzymes that aid in digestion.

Ultresa was approved for adults and children with cystic fibrosis, a deadly inherited disease that causes thick mucus to build up in the lungs and other organs. Patients with the disease have difficulty digesting food normally because their pancreas does not make enough digestive enzyme.

The FDA also approved a pill called Viokace for adults who cannot digest food normally because of pancreatitis or surgery to remove the organ. Viokace combines the ingredient pancrelipase with a proton pump inhibitor, a drug used to reduce stomach acid.

Unapproved pancreatic enzyme products had been available for many years, but the FDA has been requiring companies to seek regulatory approval for the products since April 2010.

Both drugs are made by Bridgewater, N.J.-based Aptalis Pharma U.S. Inc.

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FDA approves 2 drugs for rare digestive disorders