Johnson & Johnson Pharmaceutical Research & Development, LLC, has received a Complete Response letter regarding its New Drug Application for ceftobiprole medocaril to treat complicated skin and skin structure infections, including diabetic foot infections.
FDA has indicated that it cannot grant marketing approval for the drug at this time. J&JPRD must conduct additional audit work of clinical investigator sites and address specific questions related to site monitoring.
Ceftobiprole is a novel cephalosporin with activity against methicillin-resistant Staphylococcus aureus, penicillin-resistant Streptococcus pneumoniae, and many clinically important gram-negative bacteria, including Pseudomonas.
J&JPRD and its partner in developing ceftobiprole, Swiss-based Basilea Pharmaceutica Ltd., are reviewing the letter and will continue to work with the FDA to resolve the questions that have been raised.