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  1. Development & Approval Process | Drugs

Tigecycline – Injection products

FDA-Identified Interpretive Criteria

  Minimum Inhibitory
Concentrations
(mcg/mL)
Disk Diffusion
(zone diameter in mm)
Pathogen S I R S I R
Staphylococcus aureus
(including methicillin-resistant
isolates)
≤0.5a - - ≥19 - -
Streptococcus spp. other than
S. pneumoniae
≤0.25a - - ≥19 - -
Streptococcus pneumoniae ≤0.06a - - ≥19 - -
Enterococcus faecalis
(vancomycin-susceptible
isolates)
≤0.25a - - ≥19 - -
Enterobacteriaceaeb ≤2 4 ≥8 ≥19 15-18 ≤14
Haemophilus influenzae ≤0.25a - - ≥19 - -
Anaerobesc ≤4 8 ≥16 - - -

S = Susceptible; I = Intermediate; R = Resistant
For disk diffusion, use paper disks impregnated with 15 mcg tigecycline

a The current absence of resistant isolates precludes defining any results other than “Susceptible.” Isolates yielding MIC results suggestive of “Nonsusceptible” category should be submitted to reference laboratory for further testing.
b Tigecycline has decreased in vitro activity against Morganella spp., Proteus spp. and Providencia spp.
c Agar dilution