Omadacycline Injection and Oral Products

FDA Identified Breakpoints for Omadacycline

For Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

	Minimum Inhibitory Concentrations (mcg/mL)			Disk Diffusion (zone diameters in mm)
Pathogen	S	I	R	S	I	R
Enterobacteriaceae ^a,†	≤4	8	≥ 16	≥18	16-17	≤15
Staphylococcus aureus (including methicillin‑resistant isolates)	≤ 0.5	1.0	≥ 2.0	≥ 21	19-20	≤18
Staphylococcus lugdunensis	≤ 0.12	0.25	≥0.5	≥ 29	26-28	≤25
Enterococcus faecalis	≤ 0.25	0.5	≥ 1.0	≥18	16-17	≤15
Streptococcus anginosus group ^b	≤ 0.12	0.25	≥ 0.5	≥ 24	18-23	≤17
Streptococcus pyogenes	≤ 0.12	0.25	≥ 0.5	≥19	16-18	≤15

S = Susceptible; I = Intermediate; R = Resistant

^† Omadacycline is not active in vitro against Morganella spp., Proteus spp., and Providencia spp.

^a Klebsiella pneumoniae and Enterobacter cloacae only

^b Streptococcus anginosus group includes S. anginosus, S. intermedius, and S. constellatus

For Community Acquired Bacterial Pneumonia (CABP)

	Minimum Inhibitory Concentrations (mcg/mL)			Disk Diffusion (zone diameters in mm)
Pathogen	S	I	R	S	I	R
Enterobacteriaceae ^a,†	≤4	8	≥ 16	≥18	16-17	≤15
Staphylococcus aureus (methicillin- susceptible isolates only)	≤ 0.25	0.5	≥ 1.0	≥ 23	21-22	≤20
Haemophilus species ^b	≤2	4	≥ 8	≥ 20	17-19	≤16
Streptococcus pneumoniae	≤0.12	0.25	≥ 0.5	≥25	23-24	≤22

S = Susceptible; I = Intermediate; R = Resistant

^† Omadacycline is not active in vitro against Morganella spp., Proteus spp., and Providencia spp.

^a Klebsiella pneumoniae only

^b Haemophilus species includes H. influenzae and H. parainfluenzae