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FDA partially grants petitions on bioequivalence guidance for generic Pentasa and Asacol

This article was originally published in Scrip

Executive Summary

The US FDA opposes the idea that applicants of generic or "follow-on" formulations of extended or delayed-release oral mesalamine drug products need to show bioequivalence to ulcerative colitis treatments Pentasa or Asacol through data from comparative clinical endpoint studies. This has dampened attempts by Shire and Warner Chilcott to use the citizen's petition process to put in place such criteria.

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