Drugs

Antifungal Susceptibility Test Interpretive Criteria

This web page provides information about the in vitro susceptibility of fungi to certain drugs.

The safety and efficacy of these drugs in treating clinical infections due to such fungi may not have been established in adequate and well-controlled clinical trials and the clinical significance of such susceptibility information in those instances is unknown.

The approved product labeling for specific drugs provides the uses for which the product is approved.

Labeling for these products can be found at Drugs@FDA or FDA Online Label Repository.

Recognized Standards

Performance Methods and Quality Control 

FDA recognizes consensus standards for performance standards, methods standards, and quality control parameter standards including ranges for antimicrobial susceptibility testing.

Susceptibility Test Interpretive Criteria

The table below lists antifungal drugs and indicates which, if any, susceptibility test interpretive criteria, also known as “breakpoints” (abbreviated as STIC), are recognized or identified by FDA for that drug.

With certain exceptions and additions, identified in the table, 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)

If the table indicates that STIC for a drug are included in CLSI M60 and there are no additions or exceptions, CLSI M60 contains all of the STIC recognized by FDA for that drug.

FDA recognition of STIC standard(s) for a drug does not include recognition of epidemiological cutoff values (ECVs) for that drug.

FDA recognition of STIC standard(s) for a drug does include recognition of surrogate testing methods for that drug.

Susceptibility Test Interpretive Criteria Recognized or Otherwise Identified by FDA

The hyperlinks included for certain antifungal drugs in the table below lead to information concerning:

  • Exceptions to the recognized standard of CLSI M60
  • Additional FDA-identified STIC for certain drug-yeast combinations not included in a recognized standard

Drug

Route of
Administration

STIC for Drug
Included in CLSI
M60 Standard

Exceptions or
Additions to CLSI
M60 Standard

Last Updated

Amphotericin B*InjectionNoNo12/13/17
AnidulafunginInjectionYesNo10/03/18
CaspofunginInjectionYesNo10/03/18
FluconazoleInjection, OralYesYes10/03/18
FlucytosineOralNoNo12/13/17
Griseofulvin*OralNoNo12/13/17
Isavuconazole*Injection, OralNoNo12/13/17
Itraconazole SolutionOralNoYes10/03/18
Itraconazole CapsulesOralNoNo12/13/17
Ketoconazole*OralNoNo12/13/17
MicafunginInjectionYesNo10/03/18
Nystatin*OralNoNo12/13/17
Posaconazole*Injection, OralNoNo12/13/17
Terbinafine*OralNoNo12/13/17
VoriconazoleInjection, oralYesNo10/03/18

*No susceptibility test interpretive criteria are recognized by FDA for this drug at this time.

Page Last Updated: 10/03/2018
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