Pancreaze Delayed Release Capsules receive FDA approval

U.S. Food and Drug AdministrationApr 13 2010

The U.S. Food and Drug Administration today approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). It is the third such product to receive FDA approval.

Pancreatic enzyme products improve food digestion in patients whose bodies do not produce enough pancreatic enzymes. This includes people who have conditions such as cystic fibrosis, chronic pancreatitis, pancreatic tumors, or removal of all or a part of the pancreas.

Until today, Creon, manufactured by Abbott Products, Inc. (formerly Solvay Pharmaceuticals), and Zenpep, manufactured by Eurand Pharmaceuticals, were the only FDA-approved pancreatic enzyme products on the market.

Today's approval of Pancreaze, manufactured by Johnson & Johnson, increases the supply of FDA-approved PEPs for the estimated 200,000 or more patients in the United States who need these products. Approved pancreatic enzyme products meet FDA standards for safety, efficacy, and product quality.

"The approval of Pancreaze, along with Creon and Zenpep, allows patients and healthcare professionals to choose the approved pancreatic enzyme product that is appropriate for them," said Donna Griebel, M.D., director of the FDA's Division of Gastroenterology Products.

Unapproved versions of pancreatic enzyme products have been available for many years. In October 2007, FDA established a date of April 28, 2010 for the makers of unapproved pancreatic enzyme products to stop manufacturing and distributing unapproved products. Supplies of approved PEPs are expected to meet demand.

Currently, the FDA is working with approved PEPs manufacturers, patient advocacy groups, and health care professional organizations to make the public aware of the availability of pancreatic enzyme products. Patients with questions about their current PEP or making a switch to a different pancreatic enzyme product should consult with their healthcare provider.