U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Development Resources
  5. Rezafungin Injection
  1. Development Resources

Rezafungin Injection

Recognized Interpretive Criteria

FDA identified interpretive criteria

 

Minimum Inhibitory Concentrations
(mcg/mL)
Broth Microdilution
at 24 Hours

Disk Diffusion
(zone diameters in mm)
Disk Diffusion at 24 Hours

Pathogen

S

I

R

S

I

R

Candida albicans

≤0.12

-

-

≥13

-

-

Candida glabrata

≤0.12

-

-

≥ 15

-

-

Candida parapsilosis

M27M44S standard is recognized

≥9

-

-

Candida tropicalis

≤0.12

-

-

≥ 14

-

-

S = Susceptible; I = Intermediate; R = Resistant

Exception to the recognized standard of CLSI M27M44S
For the species listed below, susceptibility test interpretive criteria are not recognized at this time:
Candida auris
Candida dubliniensis
Candida krusei

Back to Top