Pink Sheet is part of the Business Intelligence Division 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

Multaq REMS May Be Revamped As Label Adds New Risks

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

Advertisement

Related Content

Merck Drops Development Of Cardiome’s Oral Vernakalant
EMA's Restriction Of Multaq Indication Could Spell Death Knell For The Drug In Europe
Sanofi Halts Multaq Trial Early Due To Cardiac Events
Where A REMS Didn't Help: Sanofi Must Deal With Liver Injuries With Multaq
Sometimes It Takes Two NDAs For One Approval: Multaq Odyssey Shows FDA In Search Of Reassurance In Tricky Antiarrhythmic Field
FDA Approves Multaq With REMS, Without Mortality Claim
Multaq Panel Resolves Mortality Concerns, Looks At Restricted Claims

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS073190

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