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


With Zurampic, FDA Again Made Do With Sorry State Of Regulatory Science In Gout

Executive Summary

Zurampic, which AstraZeneca licensed to Ironwood, pushed the limits of FDA's tolerance of the regulatory compromises agency has had to make in gout; our Drug Review Profile shows how statistician's case against approval received serious consideration, although the agency ultimately valued consistency with previous approvals in the space.


Related Content

Duzallo Approval Opens Gout Opportunity For Ironwood
Drug Review Profiles: Behind The Scenes At US FDA
US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews
A Cautious Guide To The Interpretation Of Clinical Trials From NEJM
What Better Gout Trials Might Look Like
AstraZeneca’s Gout Drug Lesinurad Hobbled By Renal Risk
Score One For FDAAA: Uloric Approval Was Clinched By Post-Market Powers
Regulatory Briefings: FDA's "Internal Advisory Committees"
Cardiome Oxyprim, Chronic Gout Drug Trials May Use Surrogate Endpoints For Approval, Cmte. Says


Related Companies

Related Deals

What to read next




Ask The Analyst

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

All set! This Question has been sent to 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