US FDA approves Johnson & Johnson's Pancreaze; clears two generics for Mylan

US drug major Johnson & Johnson says that the Food and Drug Administration has approved Pancreaze Delayed Release Capsules, its pancreatic enzyme product (PEP), making it the third such product to receive agency clearance.

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

The approval of Pancreaze increases the supply of FDA-approved PEPs for the estimated 200,000 or more patients in the USA who need these products, the agency said. "The approval of Pancreaze, along with Creon and Zenpep, allows patients and health care professionals to choose the approved pancreatic enzyme product that is appropriate for them," said Donna Griebel, Director of the FDA's Division of Gastroenterology Products.