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
| Date | Article |
|---|
| 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 |
Further information
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