CREON® MINIMICROSPHERES® Update Following Federal Register Notice about Approval of All Pancreatic Enzyme Products On April 27, 2004, the FDA published a Federal Register notice stating that all manufacturers of pancreatic enzyme products must secure FDA approval of their products within the next four years in order to remain available to patients. The FDA is seeking to standardize the formulation, dosage and manufacturing processes of pancreatic enzyme products, which will improve the standards of safety and effectiveness for these drugs. We applaud the FDA for this action.  The FDA’s action requires consistency among pancreatic enzyme products and will positively affect thousands of individuals with cystic fibrosis (CF) and other pancreatic conditions.  Solvay Pharmaceuticals manufactures CREON® MINIMICROSPHERES® (pancrelipase delayed-release capsules, USP) a pancreatic enzyme supplement for the treatment of pancreatic exocrine insufficiency as commonly associated with CF or chronic pancreatitis.  Pancreatic exocrine insufficiency is a condition in which there is a shortage of digestive enzymes necessary to digest the fats, proteins and carbohydrates contained in food.  This can lead to malnutrition and death. To our knowledge we are the first manufacturer of enteric-coated pancreatic enzyme products to have already submitted an NDA.  We are working with the FDA through the NDA process to obtain approval of our product.   Solvay Pharmaceuticals has 100 years of experience with pancreatic enzyme products. The CREON® brand is the top-prescribed pancreatic enzyme drug worldwide, and has been marketed in the U.S. for more than 15 years. The NDA requirement will improve the quality of enzyme products available to patients because it will eliminate “pseudo-generic” pancreatic enzymes. Such products claim to be generic equivalents, but have not demonstrated similar safety and efficacy through bioequivalence testing. In fact, the FDA concluded that, “Because of the complexity of pancreatic extract products, it is unlikely that currently available physiochemical and biological analytical tools would be able to demonstrate that the active ingredients in pancreatic extract products from two different manufacturers are the same.”  Pharmacists should not substitute another pancreatic enzyme for the product prescribed by a physician until FDA-approved bioequivalent products become available.  For more information about the Federal Register notice, contact the U.S. Food and Drug Administration at 888-INFO-FDA or the Cystic Fibrosis Foundation at 1-800-FIGHT CF (www.cff.org).