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Ceftobiprole Approval Status

FDA Approved: No
Generic name: ceftobiprole
Company: Johnson & Johnson Consumer Inc.
Treatment for: Skin and Structure Infection

Ceftobiprole is an investigational antibiotic for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.

In December 2009, Johnson Pharmaceutical Research & Development, LLC announced the receipt of a Complete Response Letter from the FDA, advising the company that the New Drug Application (NDA) for ceftobiprole had not been approved.

Development Status and FDA Approval Process for ceftobiprole

DateArticle
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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