Eurand Pharmaceuticals announced that FDA-approved Zenpep (pancrelipase delayed-release capsules) is available for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions. Zenpep is a porcine-derived pancreatic enzyme replacement product with 100% labeled lipase content, without overage. Historically, pancreatic enzyme products were not subject to FDA approval, and thus resulted in inconsistent quality. Eurand will no longer be supplying all strengths of its non-FDA approved pancrelipase capsules.
Zenpep is approved for use in infants, children, and adults. The capsule may be opened and its contents sprinkled on food for administration to infants, very young children, and older adults. Zenpep is available in 4 fixed dose capsules containing lipase, protease, and amylase: 5,000USP/17,000USP/27,000USP, 10,000USP/34,000USP/55,000USP, 15,000USP/51,000USP/82,000USP, and 20,000USP/68,000USP/109,000USP.
For more information call or visit (267) 759-9400 or visit www.eurand.com.