Ceftobiprole picture pending
Page last updated 16 October 2023
- Ceftobiprole is a cephalosporin antibiotic with activity against Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus (MRSA)
- Ceftobiprole has brand names Zevtera and Mabelio outside the US
- There was great enthusiasm for ceftobiprole in ~2008 from J&J, but the FDA did not approve it. This letter was released by J&J in 2009 when it was rejected by FDA. It would have been the first anti-MRSA cephalosporin to hit the market, instead ceftaroline (approved in 2010).
- A new drug application (NDA) for ceftobiprole was submitted to the FDA in August and accepted in early October 2023. It is not FDA-approved for any indication.
- The NDA submission includes right-sided infective endocarditis; acute bacterial skin and skin structure infections; and community-acquired bacterial pneumonia
- A result on the submission is expected before mid-2024
- Ceftobiprole has demonstrated non inferiority to daptomycin for treatment of complicated Staph. aureus bacteremia
- Ceftobiprole is dosed every 8 hours in adults and available for intravenous use only
- Basilea announces FDA acceptance of New Drug Application for antibiotic ceftobiprole
- Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia
- Ceftobiprole Perspective: Current and Potential Future Indications
- FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections
This page will be updated if ceftobiprole achieves FDA approval