The FDA has approved Pancreaze (pancrelipase delayed-release capsules, from McNeil Pediatrics) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions. For many years, pancreatic enzyme products (PEPs) were not subject to FDA approval, and thus resulted in inconsistent quality. In October 2007, the FDA established a date of April 28, 2010 for the manufacturers of unapproved PEPs to stop manufacturing and distributing unapproved products. Approved PEPs meet FDA standards for safety, efficacy, and product quality. The supplies of approved PEPs are expected to meet demand.
For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm208135.htm.