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

 
• By Nancy Faigen

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.

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.

But the agency, in its joint response issued 24 August, did agree to a request of both petitioners – that...

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