FDA approves new antibiotic for S. aureus bacteremia, skin infections, and bacterial pneumonia

On April 03, 2024, the FDA approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus in bacteremia (SAB), including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections (ABSSSI); and adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia (CABP). Today’s approval of Zevtera  in pediatric patients three months to less than 18 years with CABP was supported by evidence from the CABP trial of Zevtera in adults and a trial in 138 pediatric subjects three months to less than 18 years of age with pneumonia. Patients should not use Zevtera if they have a history of severe hypersensitivity to ceftobiprole, any of the components of Zevtera, or other members of the cephalosporin antibacterial class. Zevtera was granted Priority Review, Fast Track, and Qualified Infectious Disease Product designations for the CABP, ABSSSI, and SAB indications. @ https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses?utm_medium=email&utm_source=govdelivery

 

 FDA Approves New Antibiotic for Three Different Uses
FDA Approves New Antibiotic for Three Different Uses

FDA approved a new drug to treat S. aureus bloodstream infections; acute bacterial skin & skin structure infections; and community-acquired bacterial pneumonia.

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