Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

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.

You may also be interested in...



A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions

As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.

Duzallo Approval Opens Gout Opportunity For Ironwood

Pricing for Duzallo, a fixed-dose combination of Zurampic (lesinurad) with generic allopurinol, will likely be on par with Zurampic's solo price tag of $371 per month to smooth the way with payers.

Drug Review Profiles: Behind The Scenes At US FDA

A year in our long-running series of deep dives into FDA review documents.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS118950

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