The approvable letter indicates that the ceftobiprole application is approvable, subject to completion and assessment of clinical study site inspections, assessment of clinical and microbiological data provided but not yet reviewed, and further characterization of patients with diabetic foot infections.
The new drug application was submitted to the FDA by Basilea’s co-development partner Johnson & Johnson Pharmaceutical Research and Development.
Anthony Man, CEO of Basilea, said: “We are closely working together with our development partner Johnson & Johnson Pharmaceutical Research and Development, to quickly address the questions from the FDA.”