RARITAN, N.J. The Food and Drug Administration has requested additional information and recommended additional clinical studies be conducted in order to consider a future approval of a drug developed by Johnson & Johnson.
Johnson & Johnson submitted a new drug application in May 2007 for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections. The FDA sent a complete response letter regarding ceftobiprole in this indication.
Johnson & Johnson said it intends to discuss the best path forward with the FDA as soon as possible.