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Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) received a Complete Response letter from the FDA for ceftobiprole.
December 30, 2009
By: Tim Wright
Editor-in-Chief, Contract Pharma
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) received a Complete Response letter from the FDA for ceftobiprole. The NDA was originally submitted in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections. The FDA has requested additional information and recommended additional studies be conducted in order to consider a future approval of ceftobiprole in this indication. Ceftobiprole wa...
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