Solvay Pharmaceuticals has made available Creon (pancrelipase) delayed-release capsules, a “zero-overfill” pancreatic enzyme product that targets 100% of the lipase amount indicated on the product labeling. Creon initially received FDA approval on April 30, 2009, under the new guidelines for this class of drugs, for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. The FDA-approved formulation of Creon has new Prescribing Information, a new dosing schedule, and is available in new dosage strengths. All patients who have been prescribed the previously marketed formulation of Creon will require new prescriptions.

The FDA-approved Creon formulation is available in 6,000 lipase units, 12,000 lipase units, and 24,000 lipase units dosage strengths. The previously marketed formulation of Creon will continue to be available for a brief transitional period. However, beginning July 7th, 2009 prescribers and pharmacists should begin writing and filling Creon prescriptions reflecting the new, FDA-approved dosage strengths. Creon will have new trade dress and capsule imprints to distinguish the former capsules from the current FDA-approved formulation.

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