Table 1

Clinical characteristics of antibiotics approved by US Food and Drug Administration, 2016-19

DrugIndications*FDA approved target populationSusceptible pathogens†Method of administrationNew mechanism of actionIn vitro activity v ESKAPE‡ pathogens
BezlotoxumabPrevention of recurrence of Clostridodiodes difficile infectionAdults with C difficile infection on treatment and high risk for recurrence C difficile IntravenousYesNo
DelafloxacinABSSSIAdults with ABSSSI from susceptible bacteria Staphylococcus aureus (MSSA/MRSA), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus, Staphylococcus intermedius, Streptococcus constellatus, Streptococcus pyogenes, Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, Pseudomonas aeruginosa Oral, intravenousNoYes
Meropenem-vaborbactamComplicated urinary tract infectionsAdults with complicated urinary tract infections from susceptible bacteria E coli, K pneumoniae, E cloacae spp complexIntravenousNoYes
SecnidazoleBacterial vaginosisAdult women with bacterial vaginosisMost isolates of
Bacteroides, Gardnerella vaginalis, Prevotella,
Mobiluncus, Megasphaera like type I/II
OzenoxacinImpetigoAdults and children (aged ≥2 months) with impetigo caused by S aureus or S pyogenes S aureus, S pyogenes TopicalNoYes
PlazomicinComplicated urinary tract infectionsAdults with complicated urinary tract infection from susceptible organisms with limited alternatives, including pyelonephritis E coli, K pneumoniae, Proteus mirabilis, E cloacae IntravenousNoYes
EravacyclineComplicated intra-abdominal infectionsAdults with complicated intra-abdominal infections E coli, K pneumoniae, Citrobacter freundii, E cloacae, Klebsiella oxytoca, E faecalis, Enterococcus faecium, S aureus, S anginosus, S intermedius, S constellatus, Clostridium perfringens, Bacteroides sp, Parabacteroides distasonis IntravenousNoYes
Amikacin liposome inhalation suspension Mycobacterium avium complex lung diseaseAdults with M avium complex who do not achieve negative sputum after at least 6 months of treatment, and limited alternative options (in combination with antibacterial drug) M avium InhaledNoNo
OmadacyclineABSSSI, CABPAdult patients with CABP or ABSSSI caused by susceptible microorganismsCABP: Streptococcus pneumoniae, S aureus (MSSA), Haemophilus influenzae, Haemophilus parainfluenzae, K pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, Chlamydia pneumoniae
ABSSSI: S aureus (MRSA/MSSA), S lugdunensis, S pyogenes, S anginosus, S intermedius, S constellatus, E faecalis, E cloacae, K pneumoniae
Oral, intravenousNoYes
RifamycinTraveller’s diarrhoeaAdults with traveller’s diarrhoea caused by non-invasive strains of E coli E coli OralNoNo
Imipenem-cilastatin-relebactamComplicated urinary tract infections, complicated intra-abdominal infectionsAdults with limited or no alternative treatment options for complicated urinary tract infections and complicated intra-abdominal infections(All Gram negative bacteria) complicated urinary tract infections: E cloacae, E coli, Klebsiella aerogenes, K pneumoniae, P aeruginosa.
Complicated intra-abdominal infections: Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, C freundii, E cloacae, E coli, Fusobacterium nucleatum, K aerogenes, Klebsiella oxytoca, K pneumoniae, Parabacteroides distasonis, P aeruginosa
PretomanidTuberculosisAdults with pulmonary Extensively drug resistant, treatment intolerant, or non-responsive multidrug resistance (combination with bedaquiline and linezolid) M tuberculosis OralNoNo
LefamulinCABPAdults with CABP caused by susceptible organisms S pneumoniae, S aureus (MSSA), H influenzae, L pneumophila, M pneumoniae, C pneumoniae Oral, intravenousNoYes
Omeprazole magnesium-amoxicillin-rifabutin H pylori Adults with infections H pylori OralNoNo
CefiderocolComplicated urinary tract infectionsAdults with complicated urinary tract infections from susceptible organisms with limited or no alternative treatment options E coli, K pneumoniae, P mirabilis, P aeruginosa, E cloacae complexIntravenousNoYes
  • ABSSSI=acute bacterial skin and skin structure infections; CABP=community acquired bacterial pneumonia; MSSA=methicillin sensitive Staphylococcus aureus; MRSA=methicillin resistant Staphylococcus aureus.

  • *All information for indications covered by the first FDA approval.

  • †As listed in the FDA label.

  • ‡ESKAPE=Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumanii, Pseudomonas aeruginosa, and Enterobacter spp, determined by identifying susceptible pathogens on the FDA label, and fact checked through FDA press releases.