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FDA Approves J&J’s Pancreaze

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

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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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