The complete response addresses the FDA approvable letter received in March 2008 related to the ceftobiprole new drug application (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 R&D that it considers the response a class two complete response.
Ceftobiprole obtained regulatory approval from Health Canada authorizing the marketing of Zeftera for the treatment of cSSSI including diabetic foot infections. Ceftobiprole is also currently under review by regulatory authorities in the EU, Switzerland and other countries.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International and Cilag International, a Johnson & Johnson company.
Anthony Man, Basilea’s CEO, said: “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.”