The US Food and Drug Administration (FDA) announced on May 7, 2009, the approval of pancrelipase (Creon), a pancreatic enzyme replacement product designed to help patients with cystic fibrosis or exocrine pancreatic insufficiency digest and absorb nutrients from foods. Pancrelipase is the first FDA-approved, delayed-release pancreatic enzyme replacement product to be marketed in the United States as a result of the agency's unapproved drugs initiative. Pancrelipase, which contains a mixture of digestive enzymes extracted from the pancreas of pigs, helps patients lacking the required enzymes to digest fats, proteins, and sugars from food. Pancrelipase is approved for use in both pediatric and adult patients.The FDA had required the manufacturer of pancrelipase to submit, and the agency has approved, a Risk Evaluation and Mitigation Strategy, which includes a Medication Guide, to advise patients on the risks associated with high doses of pancrelipase, and the theoretical risk of transmission of viral disease from pigs to patients. The agency cautions that fibrosing colonopathy can result from high-dose use of pancrelipase. However, the risk may be reduced through adherence to dosing instructions in the labeling.“The risks of a rare bowel disorder and viral transmission described in the Medication Guide are considered to be risks related to all porcine-derived pancreatic enzyme products, including pancrelipase,” the FDA states. “Instructions for dosing based on weight and age should be followed carefully. Creon may be sprinkled on food. Because Creon is a delayed-release drug, patients should never crush or chew the capsule as this would cause an early release of the enzymes and a reduction in enzyme activity.”“The approval of Creon will allow patients to have access to an approved pancreatic enzyme replacement product that meets FDA standards for effectiveness, safety, and manufacturing consistency,” said Donna Griebel, MD, director, Division of Gastroenterology Products within FDA's Center for Drug Evaluation and Research (CDER).The FDA's Office of Compliance and Office of New Drugs within CDER worked with pancrelipase's manufacturer, Solvay Pharmaceuticals, through the agency's unapproved drugs initiative to help the company become compliant with federal laws by obtaining FDA approval. The agency continues to encourage the manufacturers of all other unapproved pancreatic enzyme products (PEPs) to work with the agency to obtain market approval. All PEPs must obtain FDA approval by April 28, 2010, or be removed from the marketplace.For more information on pancrelipase: http://www.fda.gov/cder/drug/infopage/pancrelipase/QA.htm. The US Food and Drug Administration (FDA) announced on May 7, 2009, the approval of pancrelipase (Creon), a pancreatic enzyme replacement product designed to help patients with cystic fibrosis or exocrine pancreatic insufficiency digest and absorb nutrients from foods. Pancrelipase is the first FDA-approved, delayed-release pancreatic enzyme replacement product to be marketed in the United States as a result of the agency's unapproved drugs initiative. Pancrelipase, which contains a mixture of digestive enzymes extracted from the pancreas of pigs, helps patients lacking the required enzymes to digest fats, proteins, and sugars from food. Pancrelipase is approved for use in both pediatric and adult patients. The FDA had required the manufacturer of pancrelipase to submit, and the agency has approved, a Risk Evaluation and Mitigation Strategy, which includes a Medication Guide, to advise patients on the risks associated with high doses of pancrelipase, and the theoretical risk of transmission of viral disease from pigs to patients. The agency cautions that fibrosing colonopathy can result from high-dose use of pancrelipase. However, the risk may be reduced through adherence to dosing instructions in the labeling. “The risks of a rare bowel disorder and viral transmission described in the Medication Guide are considered to be risks related to all porcine-derived pancreatic enzyme products, including pancrelipase,” the FDA states. “Instructions for dosing based on weight and age should be followed carefully. Creon may be sprinkled on food. Because Creon is a delayed-release drug, patients should never crush or chew the capsule as this would cause an early release of the enzymes and a reduction in enzyme activity.” “The approval of Creon will allow patients to have access to an approved pancreatic enzyme replacement product that meets FDA standards for effectiveness, safety, and manufacturing consistency,” said Donna Griebel, MD, director, Division of Gastroenterology Products within FDA's Center for Drug Evaluation and Research (CDER). The FDA's Office of Compliance and Office of New Drugs within CDER worked with pancrelipase's manufacturer, Solvay Pharmaceuticals, through the agency's unapproved drugs initiative to help the company become compliant with federal laws by obtaining FDA approval. The agency continues to encourage the manufacturers of all other unapproved pancreatic enzyme products (PEPs) to work with the agency to obtain market approval. All PEPs must obtain FDA approval by April 28, 2010, or be removed from the marketplace. For more information on pancrelipase: http://www.fda.gov/cder/drug/infopage/pancrelipase/QA.htm.