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  1. Development Resources

Omadacycline Injection and Oral Products

FDA Identified Interpretive Criteria

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
For disk diffusion, use paper disks impregnated with 30 mcg omadacycline

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

aKlebsiella pneumoniae and Enterobacter cloacae only

bStreptococcus 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

≥20

17-19

≤16

S = Susceptible; I = Intermediate; R = Resistant
For disk diffusion, use paper disks impregnated with 30 mcg omadacycline

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

aKlebsiella pneumoniae only

bHaemophilus species includes H. influenzae and H. parainfluenzae

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