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FDA Medication Tracker

← All approvals · Infections & vaccines · 2026

Zaynich (cefepime and zidebactam)

The FDA approved Zaynich (cefepime and zidebactam) on May 29, 2026 to treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms.
Brand name
Zaynich
Generic name
cefepime and zidebactam
FDA approval date
May 29, 2026
Approved use (FDA wording)
To treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms
Company
Wockhardt Bio Ag
Application
NDA220787
Dosage form / route
POWDER · INTRAVENOUS
Boxed warning on label
Not listed
Category on this site
Infections & vaccines

Indications and usage, from the FDA label

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. ( 1.1 ) 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. ( 1.2 ) 1.1 Complicated Urinary Tract Infections, including Pyelonephriti…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.