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Effient Review Delayed More By Management Issues Than Clinical Disputes

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

In FDA’s review of Lilly/Daiichi Sankyo’s antiplatelet agent Effient (prasugrel) – a drug with broad potential use – it is notable that the approval was delayed not by unusual clinical questions, but rather by the agency’s efforts to be exceedingly thorough and scrupulous in the review.

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