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

Takeda’s Uloric: CV Mortality Signal Leads US FDA To Ponder Regulatory Options

Executive Summary

Advisory committee will discuss whether CARES postmarketing trial showing 34% increased risk of cardiovascular death for febuxostat warrants market withdrawal, use restrictions, or new labeling for the gout drug.

Advertisement

Related Content

Can A REMS Mitigate CV Risks? Avandia, Meridia Offer Point, Counterpoint
Is There A REMS In Uloric’s Future? US FDA Panelists Say Yes, Agency Says Not Likely
Recent And Upcoming FDA Advisory Committee Meetings
Drug Safety Announcement Blitz Highlights Gottlieb's PR Savvy As Shutdown Drags On
Shutdown Week Three: Sponsors With Upcoming User Fee Dates Should Start Sweating
Diabetes Drugs: Longer, Broader Phase II/III Trials Could Replace CV Outcomes Trials, US Panel Says
Zelnorm's Return: US FDA Panel Hands Down Split Decision On Constipation Drug's Target Population
Waiting For Next Regulatory Shoe To Drop For Takeda's Gout Drug Uloric
Score One For FDAAA: Uloric Approval Was Clinched By Post-Market Powers
Takeda Uloric Cleared For Gout Indication

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS124527

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