Ceftobiprole FDA 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 Timeline for ceftobiprole
|Dec 30, 2009||FDA Issues Complete Response Letter for Ceftobiprole|
|Sep 3, 2009||FDA accepts for review the Complete Response submission to ceftobiprole NDA|
|Nov 26, 2008||FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections|
|Sep 15, 2008||FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter|
|Mar 18, 2008||FDA Issues Approvable Letter for Ceftobiprole for Treatment of
Complicated Skin Infections|
|Feb 13, 2008||FDA 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, 2008||Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective
Drugs Advisory Committee Meeting|
|Jul 18, 2007||U.S. FDA and European EMEA Accept Registration Applications for
Ceftobiprole, Novel Anti-MRSA Broad-Spectrum Cephalosporin|
|May 18, 2007||New Drug Application Submitted For Novel Investigational AntibioticCeftobiprole|
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