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  1. Development & Approval Process (Drugs)

Omadacycline Injection and Oral Products

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.

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

≥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.

a Klebsiella pneumoniae only

b Haemophilus species includes H. influenzae and H. parainfluenzae