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  1. Development Resources

Lefamulin Oral and Injection Products

FDA Identified Interpretive Criteria

 

Minimum Inhibitory Concentration
(mcg/mL)

Disk Diffusion
(zone diameter in mm)

Pathogen

S

I

R

S

I

R

Staphylococcus aureus (methicillin-susceptible isolates)

M-100 standard is recognized

Streptococcus pneumoniae

M-100 standard is recognized

Haemophilus influenzae

M-100 standard is recognized

S = Susceptible; I = Intermediate; R = Resistant

For disk diffusion, use paper disks impregnated with 20 mcg lefamulin.

Note: The current absence of resistant isolates precludes defining any results other than "Susceptible". Isolates yielding MIC results other than “Susceptible” should be submitted to a reference laboratory for further testing.

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