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Video: CREON(R) (Pancrelipase) Delayed-Release Capsules First and Only Pancreatic Enzyme Product to Receive FDA Approval Under New Guidelines
Date:5/1/2009

th placebo, representing a mean difference in CFA of 41%. CREON(R) showed statistically-significant increases in CFA for both adults (age >18 years) and adolescents (age 12-18 years). There was no relevant difference in the magnitude of response between the age groups. The incidence of adverse events (regardless of causality) was higher during placebo treatment (71%) than during CREON treatment (50%). Treatment-emergent adverse events occurring in at least two patients (greater than or equal to 6%) receiving CREON(R) or placebo were abdominal pain, abdominal pain upper, abnormal feces, cough, dizziness, flatulence, headache and weight decreased.

"As the first and only product in the pancreatic enzyme class to be FDA-approved under the new guidelines, CREON(R) helps meet a critical need for thousands of patients with EPI," said Dr. Stephen Hill, President, Solvay Pharmaceuticals, Inc. "For more than 20 years, Solvay Pharmaceuticals has been committed to the pancreatic enzyme market in the United States and is proud to bring FDA-approved CREON(R) to patients suffering from EPI."

The FDA-approved formulation of CREON(R) is targeted to become commercially available in the third quarter of 2009. The currently-marketed formulation of CREON(R) will continue to be commercially available until the launch of the FDA-approved product. Solvay Pharmaceuticals is committed to helping healthcare professionals, patients and their caregivers transition to the FDA-approved formulation of CREON(R). Solvay Pharmaceuticals has ongoing partnerships with leading professional organizations to educate healthcare professionals and to encourage proper prescribing of CREON(R).

About Exocrine Pancreatic Insufficiency and Pancreatic Enzyme Products

Exocrine Pancreatic Insufficiency (EPI) is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in
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SOURCE Solvay Pharmaceuticals
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