ceftobiproleTreatment for Skin and Structure Infection
Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting
BASEL, Switzerland, Jan. 10, 2008 - Basilea Pharmaceutica Ltd. (SWX: BSLN) announced that in accordance with the further amendment of Section 505 of the Federal Food, Drug, and Cosmetic Act, ceftobiprole, as a new chemical entity (NCE), has been assigned a review by the FDA Anti-Infective Drug Advisory Committee on February 28th, 2008.
The ceftobiprole New Drug Application (NDA) currently under review by the U.S. Food and Drug Administration (FDA) seeks an indication for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections. Ceftobiprole is the first anti-MRSA broad-spectrum cephalosporin to complete phase III clinical trials, and is being co-developed with Johnson & Johnson Pharmaceutical Research and Development, L.L.C., who submitted the NDA for ceftobiprole.
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.
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.
For further information, please contact:
Dr. Barbara Zink
Posted: January 2008
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- 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 of Complicated Skin Infections - March 18, 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 - February 13, 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