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 Approves Multaq With REMS, Without Mortality Claim

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA approves Sanofi-Aventis’ atrial fibrillation drug Multaq with a Risk Evaluation and Mitigation Strategy to ensure the drug is used only in patients whose hearts have returned to normal rhythm.

You may also be interested in...



Multaq REMS May Be Revamped As Label Adds New Risks

After several years of regulatory struggles Sanofi’s anti-arrhythmic Multaq finally got to market. But results from a new study have drawn attention to safety problems in higher-risk patients and could damage the drug’s commercial opportunity.

NICE Issues Favorable Final Draft Guidance On Sanofi-Aventis' Multaq

NICE's final appraisal determination on Sanofi-Aventis' Multaq recommends limited use in U.K. atrial fibrillation patients. In France, more favorable ratings by the Transparency Commission might mean a better price.

NICE Issues Favorable Final Draft Guidance On Sanofi-Aventis' Multaq

NICE's final appraisal determination on Sanofi-Aventis' Multaq recommends limited use in U.K. atrial fibrillation patients. In France, more favorable ratings by the Transparency Commission might mean a better price.

Related Content

Topics

UsernamePublicRestriction

Register

LL111799

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