US FDA grants priority review to Schering-Plough's Noxafil

27 February 2006

US drugmaker Schering-Plough says that the Food and Drug Administration has granted a six-month priority review for its New Drug Application for Noxafil (posaconazole) oral suspension for use in preventing serious invasive fungal infections, including both moulds and yeasts, in patients who are at high risk of developing them, such as hematopoietic stem cell transplant recipients or those with prolonged neutropenia. Additionally, the New Jersey-headquartered firm is seeking approval for the broad-spectrum triazole drug for the treatment of oropharyngeal candidiasis, including refractory infections. According to the FDA, the agent will receive a 10-month review for this indication.

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



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight