NDA 206494, held by Abbvie. Avibactam Sodium; Ceftazidime.
As of Nov 13, 2026, NDA 206494 (Avycaz), held by Abbvie, was first approved by FDA on Feb 25, 2015, with 11 approved supplements and 0 published complete response letters.
AVYCAZ is a combination of ceftazidime, a cephalosporin, and avibactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible Gram-negative microorganisms in adult and pediatric patients (at least 31 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole Complicated Urinary Tract Infections (cUTI), including Pyelonephritis Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVYCAZ and other antibacterial drugs, AVYCAZ should be used only to treat …
| Jan 26, 2024 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Dec 20, 2022 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Mar 14, 2019 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Mar 14, 2019 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Feb 1, 2018 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Jan 26, 2017 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Jun 22, 2016 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Feb 25, 2015 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AvycazEQ 0.5GM BASE;2GM/VIAL · powder;intravenous | Avibactam Sodium; Ceftazidime | RxReference drug |
| Apr 25, 2025 | Supplement 14Labeling · Standard review | Approved | |
| Feb 28, 2025 | Supplement 13Labeling · Standard review | Approved | |
| Jan 26, 2024 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Dec 20, 2022 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Dec 7, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Mar 14, 2019 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Mar 14, 2019 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Feb 1, 2018 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Jan 26, 2017 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Jun 22, 2016 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Sep 2, 2015 | Supplement 1Labeling · Standard review | Approved | |
| Feb 25, 2015 | Original applicationNew molecular entity, new combination · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
