CDER SBIA Update: FDA Revises Draft Guidance on Dabigatran Bioequivalence

FDA Revises Draft Guidance on Dabigatran Bioequivalence

The FDA today published a notice in the Federal Register announcing the availability of a revised draft guidance for industry that provides updated information on how to best demonstrate the bioequivalence (BE) of generic versions of Pradaxa (dabigatran). (Currently there are no approved generic versions of dabigatran.)

After careful examination of postmarket reports of bleeding events associated with use of dabigatran, in addition to the analysis of dabigatran studies and review of relevant literature, the FDA decided that there was a need to update the current BE criteria for dabigatran. The revised criteria take into account that dabigatran has demonstrated a steep exposure-response relationship for safety and efficacy, which means that serious consequences would occur as a result of blood levels that are either too high (i.e., increased risk of bleeding) or too low (i.e., increased risk of stroke). The revisions also account for the fact that dabigatran exhibits large within-subject variability with respect to blood levels.

FDA is committed to ensuring that generic drugs perform as expected and meet high standards. The agency believes that the revised draft dabigatran guidance will help industry better design and conduct BE studies and to help ensure that any future generic versions of dabigatran are bioequivalent to the reference listed drug