FDA approves label changes for Doribax to reflect risks
The US Food and Drug Administration has approved label changes for the antibacterial Doribax (doripenem) to warn of increased risk of death in certain patients.
The drug had been marketed by Johnson & Johnson's (NYSE; JNJ) subsidiary Janssen before the company returned its rights for Doribax to Japan’s Shionogi (TYO: 4507) last year.
The FDA has concluded that Doribax, an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (marketed in the USA under the name Primaxin by Merck & Co). Based on its analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns (The Pharma Letter January 9, 2012), the FDA have approved changes to the Doribax drug label that describe these risks.
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