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Notice of Updates

Sign up to receive FDA Recognized Antimicrobial STIC Breakpoints email notifications Little-Envelope

For information regarding prior changes to the STIC webpages, see https://www.govinfo.gov/content/pkg/FR-2019-05-03/pdf/2019-09007.pdf

Updates to Standards Recognition

As of June 10, 2019, the following standard is no longer recognized: 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.

As of June 10, 2019, with certain exceptions, FDA recognizes the standard published in: Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing. 29th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2019.

For disk diffusion, information regarding disk strength that is not included in recognized standards has been added for the following drugs:
 Delafloxacin, Eravacycline, Omadacycline, Plazomicin, Tigecyline

Updates by Drug:

Drug

Route of Administration

Action Taken

Therapeutic Category

Date

Azithromycin

Oral, Injection

For Neisseria gonorrhoeae, STIC are not recognized at this time. FDA review of these STIC is ongoing

Antibacterial

6/10/19

Cefiderocol

Injection

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

Antibacterial

11/18/19

Ceftaroline fosamil

Injection

For Staphylococcus aureus, FDA has reviewed STIC and concludes no changes are needed at this time. Rationale

Antibacterial

4/16/20

Ceftaroline fosamil

Injection

Typographical error corrected.

Antibacterial

8/29/19

Ceftolozane Tazobactam

Injection

For Enterobacteriaceae, an exception to the recognized standard is provided for Disk Diffusion. For Haemophilus influenzae, FDA identified STIC are provided. The STIC are based on dosing regimens that differ by the serious infection being treated, and this information is provided.

Antibacterial

6/10/19

Cefuroxime

Injection

For Neisseria gonorrhoeae, FDA agrees with the recognized standard that it is no longer appropriate to list STIC.

Antibacterial

6/10/19

Ciprofloxacin

Oral, Injection

For Enterobacteriaceae and Pseudomonas aeruginosa, the updated standard is recognized. Rationale

Antibacterial

6/10/19

Ciprofloxacin

Oral, Injection

For Salmonella spp., the updated standard is recognized

Antibacterial

2/28/20

Colistimethate

Injection

For Pseudomonas aeruginosa and Acinetobacter spp., FDA has reviewed these STIC and concludes that STIC cannot be recognized at this time. Rationale

Antibacterial

6/10/19

Daptomycin

Injection

FDA updated STIC (rationale)

Antibacterial

8/25/2020

Delafloxacin

Injection, Tablets

FDA identified STIC

Antibacterial

10/25/19

Imipenem-Cilastatin-Relebactam

Injection

FDA identified STIC for Acinetobacter calcoaceticus-baumannii complex and Haemophilus influenzae.

Antibacterial

6/4/2020

Lefamulin

Oral, Injection

FDA identified STIC.

Antibacterial

8/29/19

Levofloxacin

Oral, Injection

For Enterobacteriaceae and Pseudomonas aeruginosa, the updated standard is recognized. Rationale

Antibacterial

6/10/19

Levofloxacin

Oral, Injection

Salmonella spp., the updated standard is recognized

Antibacterial

2/28/20

Meropenem

Injection

For Acinetobacter spp., the standard is recognized. Rationale

Antibacterial

12/23/19

Meropenem and Vaborbactam

Injection

For Enterobacteriaceae, the updated standard is recognized.

Antibacterial

6/10/19

Ofloxacin

Oral

For Neisseria gonorrhoeae, FDA identified STIC are provided. FDA review of these STIC is ongoing.

Antibacterial

6/10/19

Ofloxacin

Oral

For Salmonella spp., the updated standard is recognized

Antibacterial

2/28/20

Omadacycline

Injection, Oral

FDA updated disk breakpoints for Streptococcus pneumoniae for community acquired bacterial pneumonia

Antibacterial

8/25/20

Omeprazole magnesium, Amoxicillin, and Rifabutin

Oral

Added drug to antibacterial susceptibility test interpretive criteria web page. No STIC identified at this time.

Antibacterial

11/18/19

Pretomanid

Oral

Added to table of antibacterial drugs. No STIC identified at this time.

Antibacterial

8/29/19

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