Generic warfarin products should demonstrate tighter bioequivalence range -- DuPont Merck petition.
Executive Summary
GENERIC WARFARIN TABLET RANGE WITHIN 87.5% TO 112.5% of labeled strength with no more than one tablet falling outside the 92.5% to 107.5% range should be required, the D.C. law firm Hyman, Phelps & McNamara argues in a Sept. 18 petition submitted on behalf of Coumadin manufacturer DuPont Merck. The petition contends that stricter bioequivalence standards than the normal 80% to 125% range are required for warfarin and other narrow therapeutic range drugs.