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  1. Development & Approval Process (Drugs)

Ertapenem – Injection products

Ertapenem – Injection products

Recognized Interpretive Criteria

Additional FDA-identified interpretive criteria

 

Minimum Inhibitory
Concentrations

(mcg/mL)

Disk Diffusion
(zone diameter in mm)

Pathogen

S

I

R

S

I

R

Enterobacteriaceae

M100 standard is recognized

Staphylococcus spp.a

≤2

4

≥8

≥19

16-18

≤15

Haemophilus influenzae and
parainfluenzae

M100 standard is recognized

Streptococcus pneumoniae

M100 standard is recognized

-

-

-

Streptococcus spp β-
Hemolytic Group

M100 standard is recognized

-

-

-

Streptococcus spp Viridans
Group

M100 standard is recognized

-

-

-

Anaerobes

M100 standard is recognized

-

-

-

S = Susceptible; I = Intermediate; R = Resistant
a The standard regarding surrogate testing is recognized.