Treats complicated urinary tract infections (cUTI) including pyelonephritis caused by…. NDA 220787, held by Wockhardt Bio AG. Cefepime Hydrochloride; Zidebactam.
As of Nov 13, 2026, NDA 220787 (Zaynich), held by Wockhardt Bio AG, was first approved by FDA on May 29, 2026, with 0 approved supplements and 0 published complete response letters.
ZAYNICH is a combination of cefepime, a cephalosporin antibacterial, and zidebactam, a beta-lactamase inhibitor and non-beta-lactam antibacterial indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms. Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZAYNICH and other antibacterial drugs, ZAYNICH should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.1 Complicated Urinary Tract Infections, including Pyelonephritis
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 2026 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZaynichEQ 2GM BASE/VIAL;1GM/VIAL · powder;intravenous | Cefepime Hydrochloride; Zidebactam | RxReference drug |
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
