U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Development Resources
  5. Notice of Updates
  1. Development Resources

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

Ceftaroline fosamil

Injection

For Staphylococcus aureus, an exception to the recognized standard is provided. FDA review of these STIC is ongoing

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

Daptomycin

Injection

For Enterococcus spp. (vancomycin-susceptible isolates only), an exception to the recognized standard is provided. FDA review of these STIC is ongoing.

Antibacterial

6/10/19

Delafloxacin

Injection, Tablets

FDA identified STIC

Antibacterial

10/25/19

Imipenem-Cilastatin-Relebactam

Injection

FDA identified STIC.

Antibacterial

7/18/19

Levofloxacin

Oral, Injection

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

Antibacterial

6/10/19

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

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

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

Pretomanid

Oral

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

Antibacterial

8/29/19

Ceftaroline fosamil

Injection

Typographical error corrected.

Antibacterial

8/29/19

Lefamulin

Oral, Injection

FDA identified STIC.

Antibacterial

8/29/19