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Advisory Cmte. Disinvitee Presented Prasugrel Concerns To Top CDER Staff

This article was originally published in Pharmaceutical Approvals Monthly

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Advisory Cmte. Disinvitee Presented Prasugrel Concerns To Top CDER Staff

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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.

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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