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# FDA Approves Allergan sNDA for Avycaz
- URL: https://www.fdaweb.com/fda-approves-allergan-snda-for-avycaz/
- Published: 2016-06-23T12:00:00.000Z
- Updated: 2026-09-14T21:11:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136037

FDA has approved an Allergan supplemental NDA for Avycaz (ceftazidime and avibactam) to include clinical data from a Phase 3 trial evaluating the drug’s use in combination with metronidazole for treating complicated intra-abdominal infections (cIAI) caused by designated susceptible microorganisms. The study showed that clinical cure rates at the Test of Cure time point met the primary endpoint of statistical non-inferiority to meropenem. Avycaz was first approved in the U.S. 2/2015 for treating adult patients with cIAI, in combination with metronidazole, and complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible bacteria, including certain Enterobacteriaceae and *Pseudomonas aeruginosa*.