Effient Review Delayed More By Management Issues Than Clinical Disputes
By
Pharmaceutical Approvals Monthly / Pharmaceutical Approvals Monthly October 2009, Vol. 14, No. 010
Drug Review Profile / Word Count: 3250 / Article # 06140100010
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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