Johnson & Johnson Gets FDA Approval For Pancreaze

Pancreaze (pancrelipase) delayed-release capsules are indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Pancreaze is a combination of porcine-derived lipases, proteases, and amylases.

Pancreaze contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.

Reportedly, FDA approval is a result of J&JPRD’s response to the 2004 FDA requirement that all pancreatic enzyme products be made available by prescription only and be approved through the new drug application process to standardise manufacturing procedures and enzyme activity in pancreatic enzyme products.

J&JPRD said that the new clinical trials evaluating safety and efficacy of Pancreaze in infants, children and adults with cystic fibrosis were the major reason to support the approval.

In addition to complying with the requirements of the Federal Register notice, the product name was changed to conform to the FDA’s current nomenclature guidance for new products.

Bruce Trapnell, MD and Francis Luther, professor of medicine and pediatrics, for school of medicine at University of Cincinnati, said: “Certain medical conditions can decrease the amount of digestive enzymes that are normally produced by the pancreas. When the body does not have enough of these enzymes, it becomes more difficult to digest fats, proteins and sugars. I’m pleased the FDA has approved Pancreaze, so that patients who are unable to produce enough pancreatic enzymes can now receive this prescription treatment.”

Additionally, J&JPRD said that Pancreaze capsules are expected to be marketed by McNeil Pediatrics, a Division of Ortho-McNeil-Pharmaceuticals, and will be available in 4,200, 10,500, 16,800 and 21,000 doses by lipase units. Pancreaze will be available in pharmacies in the next few months.