The FDA has indicated that they cannot approve the NDA for ceftobiprole at this time. They have asked Johnson & Johnson Pharmaceutical R&D (J&JPRD) to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring.
J&JPRD and its co-development partner, Switzerland-based Basilea Pharmaceutica are reviewing the complete response letter and will continue to work with the FDA to resolve questions that are outlined in the complete response letter.
Ceftobiprole is a novel, broad-spectrum, anti-MRSA cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus pneumonia and many clinically important gram-negative bacteria, including Pseudomonas.