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Pradaxa Bleeding Events Prompt FDA To Revise Generic Bioequivalence Criteria

 
• By Brenda Sandburg

Revamped ANDA instructions – among new and revised draft guidance for 58 products announced by FDA – 'account for the fact that dabigatran exhibits large within-subject variability with respect to blood levels.'

After examining post-marketing reports of bleeding events associated with Boehringer Ingelheim GMBH’s Pradaxa (dabigatran) and analyzing studies and literature on the oral anticoagulant, FDA has revised its draft guidance on how best to demonstrate bioequivalence for generic versions of the direct thrombin inhibitor.

“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...

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More from North America

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