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Category Archives: QIDP Antibiotics

All AllPhasePharma blogs dealing predominantly with a QIDP antibiotic

Treating GC in the Face of Dwindling Antibiotic Options – (1)

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Looking across the Northern border it is clear that CDC Guidelines are not universally followed even in North America. Public Health Canada still recommends cefixime for uncomplicated gonorrhea (GC), albeit at the high single oral dose of 800 mg [1]. In the US, CDC has opted for combination treatment with ceftriaxone Continue reading Treating GC in the Face of Dwindling Antibiotic Options – (1)→

No Such Thing as a Free Ride…

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..when it comes to FDA review of antibiotic NDAs.  Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions.  Many failed not because of lack of efficacy or a bad safety profile but because of changes in Continue reading No Such Thing as a Free Ride…→

A Renaissance for Old Drugs: Fosfomycin and Colistin

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Fosfomycin Who would have thought that a drug that has been around since 1969 [2] could become eligible for QIDP status in 2015? Well, Zavante Therapeutics recently garnered the coveted QIDP designation for fosfomycin IV. This formulation has been available in Europe for a quite some time but not in the Continue reading A Renaissance for Old Drugs: Fosfomycin and Colistin→