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# Allergan sNDA for Avycaz Approved by FDA
- URL: https://www.fdaweb.com/allergan-snda-for-avycaz-approved-by-fda/
- Published: 2018-02-02T12:00:00.000Z
- Updated: 2026-09-14T23:19:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140669

FDA has approved an Allergan supplemental NDA to expand the approved use of Avycaz (ceftazidime and avibactam) to include treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by the following susceptible Gram-negative microorganisms: *Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae* in patients 18 years of age or older. The expanded use is based on data from a pivotal Phase 3 study. The submission had received a priority review based on an earlier agemcy-granted qualified infectious disease product designation for the indication.

Avycaz was first approved 2/2015 for treating adult patients with complicated intra-abdominal infections, in combination with metronidazole. In 2017, an expanded use was apprpved for complicated urinary tract infections, including pyelonephritis, caused by designated susceptible Gram-negative bacteria, including certain Enterobacteriaceae and *Pseudomonas aeruginosa*.