Zevtera
Generic name: ceftobiprole medocaril
Treatment for: Bacteremia, Skin and Structure Infection, Pneumonia
FDA Published Today That It Will Not Hold an Advisory CommitteeMeeting on Ceftobiprole in the Treatment of Complicated Skin andSkin Structure Infections
BASEL, Switzerland, February 13, 2008 - Basilea Pharmaceutica (SWX:BSLN) announces that the US Food and Drug Administration (FDA) determined that the Anti-Infective Drugs Advisory Committee meeting scheduled for February 28, 2008 will not be held, as provided for under the provisions of the amendment of Section 505 of the Federal Food, Drug, and Cosmetic Act.
About Basilea
Basilea Pharmaceutica Ltd. is an integrated biopharmaceutical company headquartered in Basel, Switzerland, listed on the SWX Swiss Exchange (SWX: BSLN). The company focuses on the discovery, development and commercialization of innovative medicines for resistant bacterial infections, systemic fungal infections, and severe skin diseases.
Disclaimer This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
Posted: February 2008
Related articles
- FDA Approves Zevtera (ceftobiprole medocaril sodium) for Bacteremia, Skin and Skin Structure Infections, and Pneumonia - April 4, 2024
- Basilea Announces FDA Acceptance of New Drug Application for Antibiotic Ceftobiprole - October 2, 2023
- Basilea Announces Submission of a New Drug Application to the US Food and Drug Administration for its Antibiotic Ceftobiprole - August 4, 2023
- FDA Issues Complete Response Letter for Ceftobiprole - December 30, 2009
- FDA accepts for review the Complete Response submission to ceftobiprole NDA - September 3, 2009
- FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections - November 26, 2008
- FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter - September 15, 2008
- FDA Issues Approvable Letter for Ceftobiprole for Treatment ofComplicated Skin Infections - March 18, 2008
- Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting - January 10, 2008
- U.S. FDA and European EMEA Accept Registration Applications for Ceftobiprole, Novel Anti-MRSA Broad-Spectrum Cephalosporin - July 18, 2007
- New Drug Application Submitted For Novel Investigational Antibiotic Ceftobiprole - May 18, 2007
Zevtera (ceftobiprole medocaril) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
