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 FDA identified STIC (MIC) for Neisseria gonorrhoeae. Rationale Antibacterial 1/16/2025 Azithromycin Oral, Injection For Neisseria gonorrhoeae, FDA has reviewed STIC and concludes no changes are needed at this time. Rationale Antibacterial 10/14/2021 Aztreonam and avibactam Injection FDA identified STIC (MIC and disk diffusion) for Enterobacterales. Antibacterial 2/07/2025 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 standard (MIC and disk diffusion) for P. aeruginosa Antibacterial 1/16/2025 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 MIC standard and identifies disk diffusion STIC for S. maltophilia. Rationale Antibacterial 11/12/2024 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 recognizes M100 standard (MIC and disk diffusion) for P. aeruginosa Antibacterial 1/16/2025 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 Chloramphenicol Injection FDA does not recognize M45 standard for Abiotrophia spp., Granulicatella spp., and Aeromonas spp. Antibacterial 1/16/2025 Clindamycin Injection, Oral FDA does not recognize M45 standard for Moraxella catarrhalis Antibacterial 1/16/2025 Colistimethate Injection FDA recognizes STIC (MIC) for Enterobacterales, P. aeruginosa, and Acinetobacter spp. Rationale Antibacterial 2/12/2025 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 recognizes M100 standard (MIC and disk diffusion) for P. aeruginosa. Rationale Antibacterial 1/16/2025 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 Sulfate Injection FDA recognizes STIC (MIC) for Enterobacterales, P. aeruginosa, and Acinetobacter spp. Rationale Antibacterial 2/12/2025 Polymyxin B Sulfate 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 Rifampin Oral, Injection FDA does not recognize M45 standard for HACEK group: Haemophilus spp., Aggregatibacter spp., Cardiobacterium hominis, Eikenella corrodens and Kingella spp., and for Moraxella catarrhalis Antibacterial 1/16/2025 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 Voriconazole Tablets, Powder for Oral Suspension, Injection FDA recognizes M38M51S standard for Aspergillus fumigatus. Rationale Antifungal 1/16/2025

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