J&J gets FDA approval for Pancreaze

SILVER SPRING, Md. The Food and Drug Administration has approved a drug for diseases that affect the pancreas, the agency announced Monday.

The FDA approved Johnson & Johnson’s Pancreaze (pancrelipase) delayed-release capsules, a pancreatic enzyme product. Pancreatic enzyme products improve digestion in patients who can’t produce enough of it to digest food properly because of such pancreatic diseases as cystic fibrosis, chronic pancreatitis, pancreatic tumors and removal of the pancreas. Pancreaze is the third such product, after Abbott Products’ Creon (pancrelipase [amylase, lipase, protease]) and Eurand Pharmaceuticals’ Zenpep (pancrelipase [amylase, lipase, protease]).

“The approval of Pancreaze, along with Creon and Zenpep, allows patients and healthcare professionals to choose the approved pancreatic enzyme product that is appropriate for them,” FDA Division of Gastroenterology Products director Donna Griebel said.

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