FDA issues complete response letter for J&J's ceftobiprole

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.

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