Treats Staphylococcus aureus bloodstream infection (bacteremia) (SAB), including those…. NDA 218275, held by Istx. Ceftobiprole Medocaril Sodium.
As of Nov 14, 2026, NDA 218275 (Zevtera), held by Istx, was first approved by FDA on Apr 3, 2024, with 1 approved supplement and 0 published complete response letters.
ZEVTERA is a cephalosporin antibacterial indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, Adult patients with acute bacterial skin and skin structure infections (ABSSSI), and Adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 3, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zevtera667MG/VIAL · powder;intravenous | Ceftobiprole Medocaril Sodium | RxReference drug |
| Jun 26, 2026 | Supplement 1Labeling · Standard review | Approved | |
| Apr 3, 2024 | Original applicationNew molecular entity · 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
