FDA delays decision on Takeda's febuxostat

26 January 2009

The US Food and Drug Administration says it will not be able to complete its review of the New Drug Application for Japanese drug major Takeda's  hyperuricemia treatment febuxostat by its action date deadline, because  of delays in carrying out routine inspections at investigator sites.

The agency raised no issues with the NDA submission or the data included  in it, said Dean Sundberg, senior vice president, regulatory affairs, at  the Takeda Global Research & Development Center.

"Takeda has taken all necessary steps and provided all necessary  information at this point in the NDA review process and we await FDA's  completion of these routine inspections and look forward to receiving a  final approval date for febuxostat," he added.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK





Today's issue

Company Spotlight