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Ceftobiprole medocaril FDA Approval Status

FDA Approved: No
Generic name: ceftobiprole medocaril
Company: Basilea Pharmaceutica Ltd.
Treatment for: Skin and Structure Infection

Ceftobiprole medocaril, the prodrug of the active moiety ceftobiprole, is a cephalosporin antibiotic in development for the treatment of Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Development timeline for ceftobiprole medocaril

DateArticle
Oct  2, 2023Basilea Announces FDA Acceptance of New Drug Application for Antibiotic Ceftobiprole
Aug  4, 2023Basilea Announces Submission of a New Drug Application to the US Food and Drug Administration for its Antibiotic Ceftobiprole
Jun 28, 2022Basilea Announces Positive Results of Phase 3 ERADICATE Study with Ceftobiprole in Staphylococcus Aureus Bacteremia (SAB)
Dec 30, 2009FDA Issues Complete Response Letter for Ceftobiprole
Sep  3, 2009FDA accepts for review the Complete Response submission to ceftobiprole NDA
Nov 26, 2008FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections
Sep 15, 2008FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter
Mar 18, 2008FDA Issues Approvable Letter for Ceftobiprole for Treatment of Complicated Skin Infections
Feb 13, 2008FDA Published Today That It Will Not Hold an Advisory Committee Meeting on Ceftobiprole in the Treatment of Complicated Skin and Skin Structure Infections
Jan 10, 2008Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting
Jul 18, 2007U.S. FDA and European EMEA Accept Registration Applications for Ceftobiprole, Novel Anti-MRSA Broad-Spectrum Cephalosporin
May 18, 2007New Drug Application Submitted For Novel Investigational AntibioticCeftobiprole

Further information

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