Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

FDA Keen On Lilly’s Prasugrel: Will Advisory Committee Follow Suit?

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA says that increased risk of bleeding for prasugrel’s clear cardiovascular efficacy is a “reasonable trade.”

You may also be interested in...



The Return Of The Blockbuster? Stage Is Set For Prasugrel Approval

FDA's handling of the advisory committee meeting for Lilly/Daiichi Sankyo's platelet inhibitor prasugrel is the first signal in some time that the agency is ready to approve a primary care drug to be used in large patient populations with relatively limited restrictions

The Return Of The Blockbuster? Stage Is Set For Prasugrel Approval

FDA's handling of the advisory committee meeting for Lilly/Daiichi Sankyo's platelet inhibitor prasugrel is the first signal in some time that the agency is ready to approve a primary care drug to be used in large patient populations with relatively limited restrictions

Prasugrel REMS: Lilly Proposes MedGuide, FDA Wants More To Mitigate Risks

Lilly’s proposed REMS consists only of a Medication Guide warning of bleeding risk; FDA suggests the addition of a communication plan regarding the possible cancer risk.

Related Content

Topics

UsernamePublicRestriction

Register

LL1134044

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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