Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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)

You may also be interested in...



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.

Effient Approval Was Prolonged, But FDA Requirements May Help Sponsors

FDA's approval of Lilly/Daiichi Sankyo's Effient (prasugrel) NDA took longer than either the sponsors or FDA review management liked. Approval took more than a year-and-half to accomplish, with changes occurring to the very last day, July 10

Topics

Latest News
UsernamePublicRestriction

Register

PS051282

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel