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.
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