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# Achaogen Files NDA for New Antibiotic
- URL: https://www.fdaweb.com/achaogen-files-nda-for-new-antibiotic/
- Published: 2017-10-26T12:00:00.000Z
- Updated: 2026-09-14T22:58:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139972

Achaogen has submitted an NDA for plazomicin, indicated for treating complicated urinary tract infections, including pyelonephritis and bloodstream infections due to certain *Enterobacteriaceae* in patients who have limited or no alternative treatment options. The submission includes data from the EPIC and CARE clinical trials which evaluated the safety and efficacy of plazomicin in patients with serious infections caused by gram-negative pathogens, including carbapenem-resistant *Enterobacteriaceae*. Plazomicin previously received a Qualified Infectious Disease Product designation from the agency.