FDA Approves New Pancreatic Enzyme Product

Yael Waknine

April 13, 2010

April 13, 2010 — The US Food and Drug Administration (FDA) has approved a third pancreatic enzyme product (Pancreaze delayed-release capsules, Johnson & Johnson) for the treatment of exocrine pancreatic insufficiency resulting from cystic fibrosis, chronic pancreatitis, pancreatic tumors, pancreatectomy, and other conditions.

The product is intended to increase the supply of pancreatic enzyme products for 200,000 or more US patients who formerly relied only on FDA-approved Creon (Abbott Products, Inc) and Zenpep (Eurand Pharmaceuticals), as well as unapproved versions that have been circulating for many years but will be unavailable after April 28, 2010.

With this approval, supplies are expected to meet demand and also improve accessibility to patient-specific treatment options.

"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," said Donna Griebel, MD, director of the FDA's Division of Gastroenterology Products, in an agency news release.

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