After positive panel vote, Shionogi antibiotic scores US approval
Safety concerns linked with Shionogi’s antibiotic were put to bed by an expert panel to the FDA, who largely voted to back the drug for complicated urinary tract infections (cUTI) last month. On Friday, the US regulator followed suit, granting the treatment official approval.
The drug, branded Fetroja, will be used in patients whose (cUTI) is suspected to have been caused by Gram-negative pathogens, which are increasingly growing resistant to standard therapies.
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