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US FDA panel backs Remicade use for ulcerative colitis in children

This article was originally published in Scrip

Executive Summary

Advisers to the US FDA on 21 July said regulators should permit Johnson & Johnson unit Janssen Biotech, which recently changed its name from Centocor Ortho Biotech, to market its ulcerative colitis (UC) treatment Remicade (infliximab) to children, although the panelists did not support having identical labeling to that for the adult use indication.

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