Notices of Updates

AmikacinInjectionFDA recognizes M100 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa. Rationale Antibacterial10/22/2025AmikacinInjectionFDA does not recognize M100 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosaAntibacterial4/21/2023Amoxicillin and clavulanateOralFDA recognizes M100 standard (MIC) for Haemophilus influenzae. Rationale Antibacterial5/15/2025Amoxicillin and clavulanateOralFDA does not recognize M100 standard and provides STIC for Haemophilus influenzae.Antibacterial5/17/2022AzithromycinOral, InjectionFDA identified STIC (MIC) for Neisseria gonorrhoeae. RationaleAntibacterial1/16/2025AzithromycinOral, InjectionFor Neisseria gonorrhoeae, FDA has reviewed STIC and concludes no changes are needed at this time. RationaleAntibacterial10/14/2021Aztreonam and avibactamInjectionFDA identified STIC (MIC and disk diffusion) for Enterobacterales.Antibacterial2/07/2025CefadroxilOralFDA removed the statement “Susceptibility of Enterobacteriaceae to cefadroxil may be deduced from testing cefazolin.” RationaleAntibacterial4/27/2022CefazolinInjectionFDA 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. RationaleAntibacterial10/20/2022CefazolinInjectionFor Enterobacterales, FDA has reviewed STIC and the updated standard is recognized. RationaleAntibacterial10/14/2021CefepimeInjectionFDA recognizes M100 standard (MIC and disk diffusion) for P. aeruginosaAntibacterial1/16/2025CefepimeInjectionFDA recognizes M100 susceptible-dose dependent standard (MIC and disk diffusion) for EnterobacteralesAntibacterial6/21/2023Cefepime and EnmetazobactamInjectionFDA identified STIC (MIC and disk diffusion) for Enterobacterales and P. aeruginosa.Antibacterial2/22/2024CefiderocolInjectionFDA recognizes M100 MIC standard and identifies disk diffusion STIC for S. maltophilia. RationaleAntibacterial11/12/2024CefiderocolInjectionFDA recognizes M100 (disk diffusion) standards for Enterobacterales.Antibacterial1/31/2023CefiderocolInjectionFDA recognizes M100 MIC standard for Enterobacteriaceae.Antibacterial10/14/2021CefiderocolInjectionFDA has updated STIC and added STIC for Acinetobacter baumannii complex.Antibacterial9/25/2020CefoxitinInjectionFDA recognizes M100 standard for Staphylococcus aureus complex and Staphylococcus lugdunensis; FDA recognizes M100 disk diffusion standard for Staphylococcus epidermidis and other Staphylococci spp.Antibacterial10/04/2022Ceftaroline fosamilInjectionFDA recognizes the M100 standard (MIC and disk diffusion) for Staphylococcus aureus. RationaleAntibacterial6/25/2024Ceftaroline fosamilInjectionFor Staphylococcus aureus, FDA has reviewed the STIC and concludes no changes are needed at this time. RationaleAntibacterial4/16/2020CeftazidimeInjectionFDA recognizes M100 standard (MIC and disk diffusion) for P. aeruginosaAntibacterial1/16/2025CeftazidimeInjectionFDA concurs with CLSI to remove STIC (MIC) for S. maltophilia. RationaleAntibacterial5/15/2024Ceftobiprole medocaril sodiumInjectionFDA identified STIC for S. aureus, S. pyogenes, and Enterobacterales (MIC and disk diffusion), and for S. pneumoniae, H. influenzae and H. parainfluenzae (MIC).Antibacterial4/03/2024Ceftolozane TazobactamInjectionFDA recognizes M100 standard for Haemophilus influenzae.Antibacterial10/14/2021Ceftolozane and tazobactamInjectionFDA recognizes M100 disk diffusion standard for Enterobacterales.Antibacterial5/17/2022CiprofloxacinOral, InjectionFor Salmonella spp., the updated standard is recognized.Antibacterial2/28/2020ChloramphenicolInjectionFDA does not recognize M45 standard for Abiotrophia spp., Granulicatella spp., and Aeromonas spp.Antibacterial1/16/2025ClindamycinInjection, OralFDA does not recognize M45 standard for Moraxella catarrhalisAntibacterial1/16/2025ColistimethateInjectionFDA recognizes STIC (MIC) for Enterobacterales, P. aeruginosa, and Acinetobacter spp. RationaleAntibacterial2/12/2025ColistimethateInjectionFDA does not recognize M100 standard (MIC) for Enterobacterales, Pseudomonas aeruginosa, or Acinetobacter spp. RationaleAntibacterial1/17/2023DaptomycinInjectionFDA recognizes M100 standard (MIC) for E. faecium and Enterococcus spp. other than E. faecium. RationaleAntibacterial8/2/2024DaptomycinInjectionFDA updated STIC. RationaleAntibacterial8/25/2020DelafloxacinInjection, OralFDA identified STIC for Staphylococcus lugdunensis for Acute Bacterial Skin and Skin Structure Infections.Antibacterial10/06/2020FluconazoleInjection, OralFDA recognizes M27M44S susceptible-dose dependent standard (MIC and disk diffusion) for Candida species.Antifungal8/10/2023FosfomycinInjectionFDA identified STIC (MIC and disk diffusion) for E. coli and K. pneumoniae.Antibacterial 10/22/2025GentamicinInjectionFDA recognizes M100 standard (MIC and disk diffusion) for Enterobacterales. FDA removed STIC for Pseudomonas aeruginosa. RationaleAntibacterial10/22/2025GentamicinInjectionFDA does not recognize M100 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosaAntibacterial4/21/2023GepotidacinOralFDA identified STIC (MIC and disk diffusion) for Neisseria gonorrhoeae.Antibacterial12/11/2025GepotidacinOralFDA identified STIC (MIC and disk diffusion) for Enterobacterales, Staphylococcus saprophyticus, and Enterococcus faecalis.Antibacterial3/25/2025Imipenem-Cilastatin-RelebactamInjectionFDA recognizes M100 standard for Enterobacteriaceae, Pseudomonas aeruginosa, and anaerobes.Antibacterial10/14/2021Imipenem-Cilastatin-RelebactamInjectionFDA identified STIC for Acinetobacter calcoaceticus-baumannii complex and Haemophilus influenzae.Antibacterial6/4/2020Isavuconazonium sulfate*Oral, InjectionFDA recognizes M38M51S standard for Aspergillus fumigatus. RationaleAntifungal8/22/2025LefamulinOral, InjectionFDA recognizes M100 standard (MIC and disk diffusion) for Staphylococcus aureus (methicillin-susceptible isolates), Streptococcus pneumoniae, and Haemophilus influenzae.Antibacterial2/16/2023LefamulinOral, InjectionFDA does not recognize M100 disk diffusion standard and provides STIC for Streptococcus pneumoniae and Haemophilus influenzae.Antibacterial5/17/2022LefamulinOral, InjectionFDA recognizes M100 standard for Staphylococcus aureus, Streptococcus pneumoniae, and Haemophilus influenzae.Antibacterial10/14/2021LevofloxacinOral, InjectionFor Salmonella spp., the updated standard is recognized.Antibacterial2/28/2020LinezolidOral, InjectionFDA recognizes M100 (disk diffusion) standard for S. aureus.Antibacterial5/28/2024OfloxacinOralFor Salmonella spp., the updated standard is recognized.Antibacterial2/28/2020OmadacyclineInjection, OralFDA updated disk breakpoints for Streptococcus pneumoniae for community acquired bacterial pneumonia.Antibacterial8/25/2020OxacillinInjectionFDA concurs with the revised CLSI STIC for Staphylococcus by species level. Rationale; FDA references Cefoxitin STIC for Staphylococcus spp. as a surrogate test.Antibacterial10/04/2022PiperacillinInjectionFDA recognizes M100 standard (MIC and disk diffusion) for Enterobacterales, P. aeruginosa and Acinetobacter spp.Antibacterial9/23/2025Piperacillin and TazobactamInjectionFDA recognizes M100 standard (MIC and disk diffusion) for P. aeruginosa. RationaleAntibacterial1/16/2025Piperacillin and TazobactamInjectionFDA 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. RationaleAntibacterial3/22/2024Piperacillin and TazobactamInjectionFDA 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. RationaleAntibacterial1/17/2023PivmecillinamOralFDA recognizes M100 standard (MIC and disk diffusion) for EnterobacteralesAntibacterial4/24/2024PlazomicinInjectionFDA recognizes M100 standard (MIC and disk diffusion) for EnterobacteralesAntibacterial4/21/2023Polymyxin B SulfateInjectionFDA recognizes STIC (MIC) for Enterobacterales, P. aeruginosa, and Acinetobacter spp. RationaleAntibacterial2/12/2025Polymyxin B SulfateInjectionFDA does not recognize M100 standard (MIC) for Enterobacterales, Pseudomonas aeruginosa, or Acinetobacter spp. RationaleAntibacterial1/17/2023RezafunginInjection 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. Antifungal4/18/2023RifampinOral, InjectionFDA does not recognize M45 standard for HACEK group: Haemophilus spp., Aggregatibacter spp., Cardiobacterium hominis, Eikenella corrodens and Kingella spp., and for Moraxella catarrhalisAntibacterial1/16/2025Sulbactam and DurlobactamInjectionFDA recognizes M100 standard (MIC and disk diffusion) for Acinetobacter baumannii-calcoaceticus complex.Antibacterial6/06/2023Sulopenem etzadroxil and probenecidOralFDA identified STIC (MIC and disk diffusion) for Enterobacterales.Antibacterial10/25/2024Tedizolid phosphateOral, injectionFDA recognizes M100 (disk diffusion) standard for S. aureus, Streptococcus spp. beta-hemolytic group, and Streptococcus spp. viridans group.Antibacterial5/28/2024TelithromycinOralFDA 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).Antibacterial10/14/2021