The Food and Drug Administration (FDA) has accepted for filing the two New Drug Applications (NDAs) for the intravenous and oral formulation of Solithera (solithromycin; Cempra) as a potential treatment for community-acquired bacterial pneumonia (CABP).

The NDA submissions were based on results from two Phase 3 safety and efficacy studies of oral and intravenous solithromycin in the treatment of CABP. Positive topline results from both trials were announced in 2015. 

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Solithromycin, the first fluoroketolide, is a highly potent next-generation macrolide with in vitro and in vivo activity against S. pneumonia, community-acquired methicillin resistantS. aureus (CA-MRSA), haemophilus, enterococci, Mycobacterium avium, gonococci, and atypical bacteria (eg, legionella, chlamydia, mycoplasma and ureaplasma). It is 8-16 times more potent than azithromycin against many bacteria and has activity against most macrolide-resistant strains.

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