May 7, 2009
FDA approves pancreatic enzyme replacement
The U.S. Food and Drug Administration announced approval Thursday of the drug Creon, a pancreatic enzyme replacement.
The FDA said Creon (pancrelipase) is designed to help patients with cystic fibrosis and exocrine pancreatic insufficiency digest and absorb nutrients from foods.
The federal agency said Creon is the first FDA-approved delayed-release pancreatic enzyme replacement product to be marketed in the United States as a result of the FDA's unapproved drugs initiative.
Creon, which contains a mixture of digestive enzymes extracted from the pancreas of pigs, helps patients lacking the enzymes needed to digest fats, proteins and sugars from food. The drug is now approved for use by both U.S. pediatric and adult patients.
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 Dr. Donna Griebel, director of the FDA's division of gastroenterology products.
Creon is manufactured by Belgium's Solvay Pharmaceuticals Corp.