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J&J's enzyme treatment approved

The US Food and Drug Administration has announced the approval of Pancreaze, Johnson & Johnson's pancreatic enzyme product

The US Food and Drug Administration (FDA) has announced the approval of Pancreaze (pancrelipase), Johnson & Johnson's (J&J) pancreatic enzyme product (PEP) available as a delayed release capsule.

This is the third approval for a PEP by the FDA since 2009, following Abbott's Creon (pancreatin), and Eurand Pharmaceuticals' Zenpep (pancrelipase), and increases quality assured supply of the treatment for the estimated 200,000 US patients in need of the product.

Unapproved versions of the treatment have been available for several years, though the FDA called for makers of unapproved PEPs to cease the manufacture and distribution of unapproved products by April 28, 2010.

The agency has said it is working with various healthcare organisations and drug manufacturers to raise awareness of the availability of PEPs, advising patients with questions about the product to talk to their healthcare provider.

PEPs are nutritional supplements that improve the food digestion process in patients who do not have enough pancreatic enzymes. These patients include people with conditions such as pancreatic tumours, cystic fibrosis, and those who have had all or part of their pancreas removed.

"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 Dr Donna Griebel, director of the FDA's Division of Gastroenterology Products.

13th April 2010

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