Profiling Solithromycin: FDA AMDAC on Solithera

Police profiling based on race, sex or gender is a highly controversial practice. FDA doing the same, not so much. Profiling based on similarities to other drugs in the same category is nothing new. Class labeling can be expected for the next new B-lactam or quinolone regardless of whether during Continue reading Profiling Solithromycin: FDA AMDAC on Solithera

Nitrofurantoin – An Old Drug Resurrected Needs Prospective Scrutiny

When older drugs get reintroduced into clinical practice because pathogens have developed resistance to newer agents, it comes at the price of uncertainty. Often, older drugs were approved based on rather limited data, often considered incomplete by today’s standards.  Take colistin as an example: approved in the early 60ies, we still Continue reading Nitrofurantoin – An Old Drug Resurrected Needs Prospective Scrutiny

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

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)