Amikacin
Injection
FDA does not recognize M100 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa
Antibacterial
4/21/2023
Amoxicillin and clavulanate
Oral
FDA does not recognize M100 standard and provides STIC for Haemophilus influenzae.
Antibacterial
5/17/2022
Azithromycin
Oral, Injection
For Neisseria gonorrhoeae, FDA has reviewed STIC and concludes no changes are needed at this time. Rationale
Antibacterial
10/14/2021
Cefadroxil
Oral
FDA removed the statement “Susceptibility of Enterobacteriaceae to cefadroxil may be deduced from testing cefazolin.” Rationale
Antibacterial
4/27/2022
Cefazolin
Injection
FDA does not recognize M100 standard for cefazolin as a surrogate to predict susceptibility of oral cephalosporins when used for the treatment of uncomplicated UTI caused by Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis. Rationale
Antibacterial
10/20/2022
Cefazolin
Injection
For Enterobacterales, FDA has reviewed STIC and the updated standard is recognized. Rationale
Antibacterial
10/14/2021
Cefepime
Injection
FDA recognizes M100 susceptible-dose dependent standard (MIC and disk diffusion) for Enterobacterales
Antibacterial
6/21/2023
Cefepime and Enmetazobactam
Injection
FDA identified STIC (MIC and disk diffusion) for Enterobacterales and P. aeruginosa.
Antibacterial
2/22/2024
Cefiderocol
Injection
FDA recognizes M100 (disk diffusion) standards for Enterobacterales.
Antibacterial
1/31/2023
Cefiderocol
Injection
FDA recognizes M100 MIC standard for Enterobacteriaceae.
Antibacterial
10/14/2021
Cefiderocol
Injection
FDA has updated STIC and added STIC for Acinetobacter baumannii complex.
Antibacterial
9/25/2020
Cefoxitin
Injection
FDA recognizes M100 standard for Staphylococcus aureus complex and Staphylococcus lugdunensis; FDA recognizes M100 disk diffusion standard for Staphylococcus epidermidis and other Staphylococci spp.
Antibacterial
10/04/2022
Ceftaroline fosamil
Injection
FDA recognizes the M100 standard (MIC and disk diffusion) for Staphylococcus aureus. Rationale
Antibacterial
6/25/2024
Ceftaroline fosamil
Injection
For Staphylococcus aureus, FDA has reviewed the STIC and concludes no changes are needed at this time. Rationale
Antibacterial
4/16/2020
Ceftazidime
Injection
FDA concurs with CLSI to remove STIC (MIC) for S. maltophilia. Rationale
Antibacterial
5/15/2024
Ceftobiprole medocaril sodium
Injection
FDA identified STIC for S. aureus, S. pyogenes, and Enterobacterales (MIC and disk diffusion), and for S. pneumoniae, H. influenzae and H. parainfluenzae (MIC).
Antibacterial
4/03/2024
Ceftolozane Tazobactam
Injection
FDA recognizes M100 standard for Haemophilus influenzae.
Antibacterial
10/14/2021
Ceftolozane and tazobactam
Injection
FDA recognizes M100 disk diffusion standard for Enterobacterales.
Antibacterial
5/17/2022
Ciprofloxacin
Oral, Injection
For Salmonella spp., the updated standard is recognized.
Antibacterial
2/28/2020
Colistimethate
Injection
FDA does not recognize M100 standard (MIC) for Enterobacterales, Pseudomonas aeruginosa, or Acinetobacter spp. Rationale
Antibacterial
1/17/2023
Daptomycin
Injection
FDA recognizes M100 standard (MIC) for E. faecium and Enterococcus spp. other than E. faecium. Rationale
Antibacterial
8/2/2024
Daptomycin
Injection
FDA updated STIC. Rationale
Antibacterial
8/25/2020
Delafloxacin
Injection, Oral
FDA identified STIC for Staphylococcus lugdunensis for Acute Bacterial Skin and Skin Structure Infections.
Antibacterial
10/06/2020
Fluconazole
Injection, Oral
FDA recognizes M27M44S susceptible-dose dependent standard (MIC and disk diffusion) for Candida species.
Antifungal
8/10/2023
Gentamicin
Injection
FDA does not recognize M100 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa
Antibacterial
4/21/2023
Imipenem-Cilastatin-Relebactam
Injection
FDA recognizes M100 standard for Enterobacteriaceae, Pseudomonas aeruginosa, and anaerobes.
Antibacterial
10/14/2021
Imipenem-Cilastatin-Relebactam
Injection
FDA identified STIC for Acinetobacter calcoaceticus-baumannii complex and Haemophilus influenzae.
Antibacterial
6/4/2020
Lefamulin
Oral, Injection
FDA recognizes M100 standard (MIC and disk diffusion) for Staphylococcus aureus (methicillin-susceptible isolates), Streptococcus pneumoniae, and Haemophilus influenzae.
Antibacterial
2/16/2023
Lefamulin
Oral, Injection
FDA does not recognize M100 disk diffusion standard and provides STIC for Streptococcus pneumoniae and Haemophilus influenzae.
Antibacterial
5/17/2022
Lefamulin
Oral, Injection
FDA recognizes M100 standard for Staphylococcus aureus, Streptococcus pneumoniae, and Haemophilus influenzae.
Antibacterial
10/14/2021
Levofloxacin
Oral, Injection
For Salmonella spp., the updated standard is recognized.
Antibacterial
2/28/2020
Linezolid
Oral, Injection
FDA recognizes M100 (disk diffusion) standard for S. aureus.
Antibacterial
5/28/2024
Ofloxacin
Oral
For Salmonella spp., the updated standard is recognized.
Antibacterial
2/28/2020
Omadacycline
Injection, Oral
FDA updated disk breakpoints for Streptococcus pneumoniae for community acquired bacterial pneumonia.
Antibacterial
8/25/2020
Oxacillin
Injection
FDA concurs with the revised CLSI STIC for Staphylococcus by species level. Rationale;
FDA references Cefoxitin STIC for Staphylococcus spp. as a surrogate test.
Antibacterial
10/04/2022
Piperacillin and Tazobactam
Injection
FDA has updated STIC (MIC and disk diffusion) for P. aeruginosa. FDA identified a susceptible-dose dependent breakpoint. FDA does not recognize M100 standard for a susceptible, intermediate, and resistance breakpoints. Rationale
Antibacterial
3/22/2024
Piperacillin and Tazobactam
Injection
FDA has updated STIC (MIC and disk diffusion) for Enterobacterales. FDA has recognized M100 standard for susceptible and resistant breakpoints and updated an intermediate breakpoint. FDA does not recognize M100 standard for a susceptible dose dependent breakpoint. Rationale
Antibacterial
1/17/2023
Pivmecillinam
Oral
FDA recognizes M100 standard (MIC and disk diffusion) for Enterobacterales
Antibacterial
4/24/2024
Plazomicin
Injection
FDA recognizes M100 standard (MIC and disk diffusion) for Enterobacterales
Antibacterial
4/21/2023
Polymyxin B
Injection
FDA does not recognize M100 standard (MIC) for Enterobacterales, Pseudomonas aeruginosa, or Acinetobacter spp. Rationale
Antibacterial
1/17/2023
Rezafungin
Injection
FDA identified STIC (MIC and disk diffusion) for C. albicans, C. glabrata, and C. tropicalis.
FDA has reviewed STIC (MIC) for C. parapsilosis, and the M27M44S standard is recognized.
FDA identified STIC (disk diffusion) for C. parapsilosis.
Antifungal
4/18/2023
Sulbactam and Durlobactam
Injection
FDA recognizes M100 standard (MIC and disk diffusion) for Acinetobacter baumannii-calcoaceticus complex.
Antibacterial
6/06/2023
Sulopenem etzadroxil and probenecid
Oral
FDA identified STIC (MIC and disk diffusion) for Enterobacterales.
Antibacterial
10/25/2024
Tedizolid phosphate
Oral, injection
FDA recognizes M100 (disk diffusion) standard for S. aureus, Streptococcus spp. beta-hemolytic group, and Streptococcus spp. viridans group.
Antibacterial
5/28/2024
Telithromycin
Oral
FDA has removed telithromycin STIC as the drug is no longer approved in any application under section 505 of the FD&C Act (see 84 FR 47309).
Antibacterial
10/14/2021
Tobramycin
Injection
FDA does not recognize M100 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa
Antibacterial
4/21/2023
