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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

n doses of CREON(R) exceed 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day). Care should be taken to ensure that CREON(R) is not chewed or retained in the mouth to avoid irritation of oral mucosa. Caution should be exercised when prescribing CREON(R) to patients with gout, renal impairment, or hyperuricemia. There is theoretical risk of viral transmission with all pancreatic enzyme products including CREON(R). Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.

CREON(R) has been approved with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks. As part of the REMS, a Medication Guide with important dosing and safety information applicable to this class of products, including CREON(R), is provided for patients and caregivers, with an emphasis on understanding the risk of fibrosing colonopathy as well as the importance of not over- or under-dosing. The FDA requires that the Medication Guide be handed out with every prescription for the drug dispensed.

Full prescribing information for FDA-approved CREON(R) will be distributed when the product becomes commercially available, targeted for the third quarter of 2009. For full safety and prescribing information about the current and FDA-approved formulations of CREON(R), visit www.CREON-US.com.

Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit www.solvaypharmaceuticals-us.com.

Solvay Pharmaceuticals is a research driven group of companies that constitutes the global pharmaceutical business of the Solvay Group. These companies seek to f
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SOURCE Solvay Pharmaceuticals
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