Abstract
Digestive Products Inc. on May 18 announced the approval of Pertzye delayed-release oral capsules for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis or other conditions. Pertzye contains porcine-derived lipases, proteases, and amylases and was previously marketed as an unapproved pancreatic insufficiency treatment under the name Pancrecarb MS-16. A Digestive Products spokesman said the company hopes to make Pertzye available in pharmacies in mid-July. The product is the sixth pancrelipase product to be approved by FDA since the agency began a program to ensure that all pancreatic insufficiency products on the U.S. market are of acceptable quality. Pertzye is not interchangeable with other pancrelipase products, according to the product’s labeling. Pertzye capsules are formulated in two strengths. Each capsule of the lower-strength version contains 8,000 units of lipase, 28,750 units of protease, and 30,250 units of amylase. The higher-strength formulation contains twice those amounts of each enzyme.
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