Basilea Pharmaceutica Ltd. announces that the US 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.