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On June 19, 2017, the FDA announced approval of delafloxacin (Baxdela) for treatment of acute bacterial skin and skin-structure infections (ABSSSIs) caused by various gram-positive and gram-negative pathogens, including Staphylococcus aureus (methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] strains), S. haemolyticus, S. lugdunensis, Streptococcus pyogenes, S. agalactiae, S. anginosus group, Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, and Pseudomonas aeruginosa.
In two phase III, randomized, double-blind, multicenter trials totaling 1510 patients treated for 5 to 14 days, delafloxacin was noninferior to vancomycin 15 mg/kg plus aztreonam. Recommended doses of delafloxacin are 300 mg (20…