Tag Archives: nitrofurantoin

BLUJEPA / Gepotidacin APPROVED FOR UNCOMPLICATED UTI – 1

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GSK’s pipeline in anti-infectives is impressive. It comprises drugs for bacterial, mycobacterial, fungal, viral infections, and for malaria; in addition, they have a number of vaccines in development.  Several antibiotics are listed on their website targeting UTI pathogens, and one of them was just approved, namely gepotidacin / Blujepa, a Continue reading BLUJEPA / Gepotidacin APPROVED FOR UNCOMPLICATED UTI – 1→

The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?

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Any FDA meeting is a high-stakes game for industry:  One never knows how the discussions will go. Some oddball issue may take center stage and usurp much time, creating an unbalanced perspective.  At other times, simple issues seem to create controversy, questions are not properly understood in the context of Continue reading The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?→

AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1

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Only now, a few days before the actual AMDAC meeting, the FDA’s Briefing Document becomes available to the public.  The topic of the December 5th meeting:  Reappraisal of the risk/benefit of fluoroquinolones (FQ) in approved but “mild, self-limiting” disease indications in light of new post-approval safety issues. The document is 617 Continue reading AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1→