Effient REMS: FDA Role In Intro Grows; No Safe Use Restrictions
Executive Summary
FDA is going to be checking to make sure how many physicians Lilly/Daiichi reach in five key medical practice areas during the first two years of the launch of Effient (prasugrel)
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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.
Effient Review Delayed More By Management Issues Than Clinical Disputes
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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