TABLE 1.
Summary of antimicrobial drugs approved since 2010 and times to AST devices
| Antimicrobial agent | Month/year approved by FDA | Time (mo)a to: |
|||
|---|---|---|---|---|---|
| First disk clearanceb | First gradient diffusion strip clearance | Manual MIC test (Sensititre) clearance | Rapid automated AST device clearance | ||
| Delafloxacin | 6/2017 | 2 | 2 | 2 | NA |
| Meropenem-vaborbactam | 8/2017 | 2 | 4 | 4 | 6 |
| Ceftazidime-avibactam | 2/2015 | 8 | 7 | 10 | 25 |
| Ceftolozane-tazobactam | 12/2014 | 11 | 19 | 8 | 36 |
| Dalbavancin | 5/2014 | ND | 25 | 14 | NA |
| Oritavancin | 8/2014 | ND | NA | 7 | NA |
| Tedizolid | 6/2014 | NA | 36 | 15 | NA |
| Ceftaroline | 5/2010 | 7 | 29 | 14 | 34 |
a
Times were rounded to the nearest month. NA, not available; ND, no disk test is possible due to drug characteristics.
b
The average time to clearance, from the time the 510(k) data package is submitted to the FDA, is 42 days for the disk manufacturers that participated in the sponsor's clinical trials.