Drugs

Notice of Updates

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On October 4, 2018, FDA updated the format of the Antifungal Susceptibility Interpretive Criteria web pages for clarity, in response to stakeholder feedback.

On June 26, 2018, FDA updated the format of the Antibacterial Susceptibility Test Interpretive Criteria web pages for clarity, in response to stakeholder feedback.

Updates to Standards Recognition

As of October 4, 2018, the following STIC standards are no longer recognized (for information regarding recognition of methods and quality control standards see Recognized Consensus Standards):

  • Clinical and Laboratory Standards Institute (CLSI). Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement. CLSI document M27-S4 (2012). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA. (CLSI M27-S4)
  • Clinical and Laboratory Standards Institute (CLSI). Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline – Second Edition. CLSI document M44-S3 (2009). Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 500, Wayne, Pennsylvania 19087, USA. (CLSI M44-S3)
  • Clinical and Laboratory Standards Institute (CLSI). Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement. CLSI document M27-S3 (2008). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA. (CLSI M27-S3)

As of October 4, 2018, with certain exceptions, FDA recognizes the standard published in:

  • Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antifungal Susceptibility Testing of Yeasts. 1st ed. CLSI supplement M60 (2017). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA. (CLSI M60)

As of June 26, 2018, the following standard is no longer recognized: Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing. 27th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2017.

As of June 26, 2018, with certain exceptions, FDA recognizes the standard published in: Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing. 28th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2018.

Updates by Drug:

Drug

Route of Administration

Action Taken

Therapeutic Category

Date

Bismuth subcitrate potassium, Metronidazole, and Tetracycline hydrochloride

Oral

Added drug to antibacterial susceptibility test interpretive criteria web page. No STIC recognized or added by FDA.

Antibacterial

02/09/18

Ceftazidime Avibactam

Injection

FDA recognizes M100 standard for Enterobacteriaceae and Pseudomonas aeruginosa

Antibacterial

06/26/18

Ceftolozane Tazobactam

Injection

FDA recognizes M100 standard for disk diffusion for Enterobacteriaceae

Antibacterial

06/26/18

Clarithromycin

Oral

FDA recognizes CLSI M45 standard for clarithromycin for H. pylori.

Antibacterial

02/09/18

Dalbavancin

Injection

FDA recognizes M100 standard for Staphylococcus aureus, Enterococcus spp. (vancomycin-susceptible isolates only), Streptococcus spp β- Hemolytic Group, Streptococcus spp Viridans Group

Antibacterial

06/26/18

Eravacycline

Injection

Added drug to antibacterial susceptibility test interpretive criteria web page. FDA identified STIC for eravacycline injection

Antibacterial

08/28/18

Fluconazole

Injection, Oral

FDA identifies exceptions to the recognized standard for Fluconazole. The term “SDD” is not recognized pending further clarification of the definition of the term by standards development organizations.

Antifungal

10/03/18

Flucytosine

Injection

FDA withdraws recognition of Susceptibility Test Interpretive Criteria for Flucytosine as there are not sufficient clinical or other data to support these criteria.

Antifungal

10/03/18

Isoniazid, Pyrazinamide, and Rifampin

Oral

Added drug to antibacterial susceptibility test interpretive criteria web page. No STIC recognized or added by FDA.

Antibacterial

02/09/18

Itraconazole

Injection, Oral

FDA identifies Susceptibility Test Interpretive Criteria for Itraconazole and Candida albicans. The current MIC distribution data demonstrates that the sensitivity of C. albicans to itraconazole has not changed over time. Therefore, the in-vitro activity and clinical response data reviewed previously by FDA and described in product labeling continue to support these interpretive criteria for C. albicans.

Antifungal

10/03/18

Lansoprazole, Amoxicillin, and Clarithromycin

Oral

Added drug to antibacterial susceptibility test interpretive criteria web page. No STIC recognized or added by FDA.

Antibacterial

02/09/18

Omadacycline

Injection, Oral

Added drug to antibacterial susceptibility test interpretive criteria web page.FDA identified STIC for omadacycline injection.

Antibacterial

10/03/18

Piperacillin Tazobactam

Injection

FDA recognizes revised M100 standard for Anaerobes

Antibacterial

06/26/18

Plazomicin

Injection

Added drug to antibacterial susceptibility test interpretive criteria web page.
FDA identified STIC for plazomicin injection

Antibacterial

06/26/18

Rifabutin

Oral

Added drug to antibacterial susceptibility test interpretive criteria web page. No STIC recognized or added by FDA.

Antibacterial0

04/26/18

Rifapentine

Oral

Added drug to antibacterial susceptibility test interpretive criteria web page. No STIC recognized or added by FDA.

Antibacterial

02/09/18

Rifaximin

Oral

Added drug to antibacterial susceptibility test interpretive criteria web page. No STIC recognized or added by FDA.

Antibacterial

02/09/18

Tedizolid

Oral, Injection

Due to test performance concerns, FDA withdraws recognition of all disk diffusion interpretive criteria.

Antibacterial

06/26/18

 

Page Last Updated: 10/05/2018
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