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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
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 was licensed from Swiss-based Basilea Pharmaceutica Ltd. in February 2005. J&JPRD received an Approvable Letter for the ceftobiprole filing in March 2008, which J&JPRD responded to in August 2008. In November 2008, the company received a Complete Response letter recommending additional site audits. The company completed those audits and included the results in its June 2009 response to the FDA.
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