Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), has announced that it received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.
J&JPRD, along with its co-development partner, Swiss-based Basilea Pharmaceutica Ltd., is reviewing the agency's letter and will work quickly to resolve any outstanding issues. The NDA for ceftobiprole was submitted to the FDA last May.
An application for the use of ceftobiprole in adults in the same indication is currently under regulatory review in Europe, Australia, Canada and in other countries.
J&JPRD is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.