ceftobiproleTreatment for Skin and Structure Infection
FDA Accepts for Review the Complete Response to Ceftobiprole NDA Approvable Letter
FDA accepts for review the Complete Response to ceftobiprole NDA Approvable Letter
BASEL, Switzerland, September 15, 2008 - Basilea Pharmaceutica Ltd. announces that the Food and Drug Administration (FDA) has accepted for review the Complete Response to the ceftobiprole New Drug Application (NDA) Approvable Letter.
The Complete Response addresses the FDA Approvable Letter received in March, 2008 related to the ceftobiprole NDA for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections. The FDA informed Basilea's co-development partner Johnson & Johnson Pharmaceutical Research and Development, L.L.C. that it considers the response a class two Complete Response.
"We are very pleased that the FDA has accepted for review our complete response to the NDA approvable letter. We have worked diligently with our partner to achieve this important step in the review process. We look forward to continue to work closely with the FDA as it moves forward with the ceftobiprole NDA submission review." commented Dr. Anthony Man, Basilea's CEO.
Ceftobiprole obtained regulatory approval from Health Canada authorizing the marketing of ZEFTERA(TM) for the treatment of complicated skin and skin structure infections including diabetic foot infections. Ceftobiprole is also currently under review by regulatory authorities in the European Union, Switzerland and other countries.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International Ltd. and Cilag GmbH International, a Johnson & Johnson company.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and 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.
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Jean-Christophe Britt, Ph.D.
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Posted: September 2008
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- 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
- Basilea Announces Review of Ceftobiprole NDA at FDA Anti-Infective Drugs Advisory Committee Meeting - January 10, 2008
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