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# FDA Approves Allergan sNDA for Avycaz
- URL: https://www.fdaweb.com/fda-approves-allergan-snda-for-avycaz-2/
- Published: 2017-02-01T12:00:00.000Z
- Updated: 2026-09-14T22:04:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137882

FDA has approved an Allergan supplemental NDA for Avycaz (ceftazidime and avibactam) to include clinical data from two Phase 3 trials in the labeling that supports the indication to treat patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative microorganisms. In Trial 1, known as RECAPTURE, Avycaz was found non-inferior to doripenem in both primary endpoints, according to the company. In Trial 2, known as REPRISE, the drug demonstrated a higher combined clinical and microbiological cure rate vs. best available therapy, including meropenem, imipenem, doripenem, and colistin. “The successful cumulative Phase 3 cUTI studies further validate the initial FDA approval of Avycaz based on Phase 2 data,” Allergan says.