Clinical characteristics of antibiotics approved by US Food and Drug Administration, 2016-19
| Drug | Indications* | FDA approved target population | Susceptible pathogens† | Method of administration | New mechanism of action | In vitro activity v ESKAPE‡ pathogens |
| Bezlotoxumab | Prevention of recurrence of Clostridodiodes difficile infection | Adults with C difficile infection on treatment and high risk for recurrence | C difficile | Intravenous | Yes | No |
| Delafloxacin | ABSSSI | Adults 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, intravenous | No | Yes |
| Meropenem-vaborbactam | Complicated urinary tract infections | Adults with complicated urinary tract infections from susceptible bacteria | E coli, K pneumoniae, E cloacae spp complex | Intravenous | No | Yes |
| Secnidazole | Bacterial vaginosis | Adult women with bacterial vaginosis | Most isolates of Bacteroides, Gardnerella vaginalis, Prevotella, Mobiluncus, Megasphaera like type I/II | Oral | No | No |
| Ozenoxacin | Impetigo | Adults and children (aged ≥2 months) with impetigo caused by S aureus or S pyogenes | S aureus, S pyogenes | Topical | No | Yes |
| Plazomicin | Complicated urinary tract infections | Adults with complicated urinary tract infection from susceptible organisms with limited alternatives, including pyelonephritis | E coli, K pneumoniae, Proteus mirabilis, E cloacae | Intravenous | No | Yes |
| Eravacycline | Complicated intra-abdominal infections | Adults 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 | Intravenous | No | Yes |
| Amikacin liposome inhalation suspension | Mycobacterium avium complex lung disease | Adults 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 | Inhaled | No | No |
| Omadacycline | ABSSSI, CABP | Adult patients with CABP or ABSSSI caused by susceptible microorganisms | CABP: 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, intravenous | No | Yes |
| Rifamycin | Traveller’s diarrhoea | Adults with traveller’s diarrhoea caused by non-invasive strains of E coli | E coli | Oral | No | No |
| Imipenem-cilastatin-relebactam | Complicated urinary tract infections, complicated intra-abdominal infections | Adults 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 | Intravenous | No | Yes |
| Pretomanid | Tuberculosis | Adults with pulmonary Extensively drug resistant, treatment intolerant, or non-responsive multidrug resistance (combination with bedaquiline and linezolid) | M tuberculosis | Oral | No | No |
| Lefamulin | CABP | Adults with CABP caused by susceptible organisms | S pneumoniae, S aureus (MSSA), H influenzae, L pneumophila, M pneumoniae, C pneumoniae | Oral, intravenous | No | Yes |
| Omeprazole magnesium-amoxicillin-rifabutin | H pylori | Adults with infections | H pylori | Oral | No | No |
| Cefiderocol | Complicated urinary tract infections | Adults 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 complex | Intravenous | No | Yes |
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.