The Cystic Fibrosis Foundation has learned that the pancreatic enzyme product Pancrease will be available in limited supply at pharmacies around the country until an updated formula called Pancreaze™ is made available this summer.
Pancreaze is manufactured by Johnson and Johnson Pharmaceutical Research and Development.
The CF Services Pharmacy, a subsidiary of the CF Foundation, expects to receive the drug and have it available for customers in early July, according to Dan Klein, senior vice president of the pharmacy.
Pancrease is no longer being manufactured, but pharmacies are able to fill prescriptions while supplies last.
All pancreatic enzyme therapies underwent a comprehensive safety review process initiated by the FDA in 2004. Previously, the enzymes were unregulated. As part of the safety review process, the FDA has now approved Pancreaze and two other enzyme therapies, Creon and ZENPEP.
Pancrecarb and Ultrase have not yet received FDA approval.
The CF Foundation continues to relay the concerns of people with CF who rely on enzymes that are not approved, and to work with the FDA to find ways to reduce the burden on these individuals. The CF Foundation encourages people with CF to work closely with a cystic fibrosis physician at an accredited CF Foundation care center to address enzyme-related problems.
More than 90 percent of people with cystic fibrosis take enzyme supplements to help absorb food and vitamins. Without pancreatic enzymes, people with CF could not survive.
Source: Cystic Fibrosis Foundation