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Article Excerpt
- First and only FDA-approved therapy for exocrine pancreatic insufficiency is now available through pharmacies and requires new prescriptions reflecting new dosage strengths -
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...
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