May 03, 2010
Creon dosing information for chronic pancreatitis and pancreatectomy approvedThe supplemental New Drug Application (sNDA) for Creon (pancrelipase delayed-release capsules, from Solvay) has been approved by the FDA to include dosing guidance in the prescribing information specific to patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. The sNDA approval was based on results of a double-blind, randomized, placebo-controlled, two-arm, parallel-group study which enrolled 54 adults with EPI due to CP or pancreatectomy. The primary efficacy endpoint was a clinical measurement of how much fat consumed by a patient is absorbed by the body rather than excreted.
For more information call (800) 354-0026 or visit www.CREON.com.