> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA OKs Zevtera Antibiotic with 3 Indications
- URL: https://www.fdaweb.com/fda-oks-zevtera-antibiotic-with-3-indications/
- Published: 2024-04-03T12:00:00.000Z
- Updated: 2026-09-14T14:27:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156701

FDA has approved Basilea Pharmaceutica International’s Zevtera (ceftobiprole medocaril sodium for injection) to treat adults with *Staphylococcus aureus* bloodstream infections, including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections; and adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia. An agency [statement](https://prnmedia.prnewswire.com/news-releases/fda-approves-new-antibiotic-for-three-different-uses-302107661.html?ref=fdaweb.com) lists the trials that supported each of the indications and the most common side effects when Zevtera is used with each indication.

The antibiotic comes with Warnings and Precautions such as increased mortality in ventilator-associated bacterial pneumonia patients (an unapproved use), hypersensitivity reactions, seizures and other central nervous system reactions, and *Clostridioides difficile*\-associated diarrhea, FDA says.

The notice says Zevtera was granted priority review, fast track, and qualified infectious disease product designations for the three indications.