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Solvay Pharmaceuticals, Inc. Announces Commercial Availability of CREON(R) (Pancrelipase) Delayed-Release Capsules
Date:7/7/2009

MARIETTA, Ga., July 7 /PRNewswire/ -- Solvay Pharmaceuticals, Inc. today announced the commercial availability of CREON(R) (pancrelipase) Delayed-Release Capsules. Now available to be filled at pharmacies nationwide, CREON(R) was approved by the Food and Drug Administration (FDA) on April 30, 2009, for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions. CREON(R) is the first and only pancreatic enzyme product (PEP) to receive FDA approval under new manufacturing guidelines for the class.

The new formulation of CREON(R) has new Prescribing Information, a new dosing schedule, and a Medication Guide to provide important dosing and safety information to patients. CREON(R) also has new dosage strengths and -- effective immediately -- requires new prescriptions for all patients who have previously been prescribed CREON(R).

CREON(R) is available in three prescription strengths dosed by lipase units. As of today, the new FDA-approved dosage strengths are CREON(R) 6,000 lipase units, CREON(R) 12,000 lipase units, and CREON(R) 24,000 lipase units. Patients already taking CREON can be transitioned to the FDA-approved CREON(R) dosage strengths on a capsule-to-capsule basis as follows.

    Former Dosage Strength             FDA-approved Dosage Strength
    CREON(R) 5            Creon(R) 6,000 units   19,000 units   30,000 units
                           Lipase                 Protease       Amylase
    CREON(R) 10           Creon(R) 12,000 units  38,000 units   60,000 units
                           Lipase                 Protease       Amylase
    CREON(R) 20           Creon(R) 24,000 units  76,000 units   120,000 units
                           Lipase                 Protease       Amylase

The FDA-approved formulation of CREON(R) includes several changes of which prescribers and pharmacists shou
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SOURCE Solvay Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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