For some explanation on that subject, the absurd off-label use of all antibiotics is a huge issue. That is true for all, nothing specific here. Go to most any third world or developing country and you can buy Cirpro for a few bucks for 2 weeks(?) worth, no prescription.
This is what is causing the problem with "super bugs". So yes, the FDA has a concern here.
OTOH, the same thing is why we need more choice in the field of antibiotics. And that is what this is, another choice for bugs that are are resistent to other antibiotics.