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Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) received approval from the FDA for its NDA for Pancreaze (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or ot
April 14, 2010
By: Tim Wright
Editor-in-Chief, Contract Pharma
Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) received approval from the FDA for its NDA for Pancreaze (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Exocrine pancreatic insufficiency is the inability to properly digest and absorb food due to a lack of enzymes made by the pancreas. Pancreaze is a combination of porcine-derived lipases, proteases, and amylases. The approval is based on clinical trials evaluating efficacy and safety in infants, children and adults with cystic fibrosis.
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