Cubist’s tedizolid NDA accepted for priority review in USA
The US Food and Drug Administration has accepted Cubist Pharmaceuticals’ (Nasdaq: CBST) New Drug Application for its investigational antibiotic tedizolid phosphate (TR-701) with Priority Review.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 20, 2014. Cubist is seeking FDA approval of tedizolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The drug came to Cubist along with its $707 million acquisition of Trius Therapeutics (The Pharma Letter July 31, 2013).
$1 billion sales by 2020 forecast
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 accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- 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
More Features in Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze