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

Score One For FDAAA: Uloric Approval Was Clinched By Post-Market Powers

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Within the review teams at FDA, there is the sentiment that the broadened safety authorities granted under the FDA Amendments Act allow the agency to approve drugs that it previously would have considered unapprovable, as an office director in the Center for Drug Evaluation and Research makes clear in the review documents for Takeda’s gout therapy Uloric (febuxostat).

You may also be interested in...



Uloric U-Turn: Gout Therapy Likely To Stay On Market Despite CV Safety Concern

US FDA would not have approved Takeda’s Uloric but for a post-market safety study commitment. Now that the study is complete and suggests a potential increased risk of mortality, however, FDA doesn’t seem inclined to pull the product.

Can A REMS Mitigate CV Risks? Avandia, Meridia Offer Point, Counterpoint

As US FDA weighs fate of Takeda’s febuxostat, advisory committee members suggest REMS to ensure prescribers have informed benefit/risk conversation with patients, but agency staff highlight design and assessment challenges for such a program.

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

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.

Related Content

Topics

UsernamePublicRestriction

Register

LL1135972

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