Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Johnson & Johnson Pharmaceutical R&D has received a complete response letter from the FDA regarding its new drug application for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.
Subscribe to our email newsletter
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.