Johnson & Johnson Gets FDA Approvable Letter for Ceftobiprole

The FDA said it needs more information to approve ceftobiprole, the product of a joint development program between the Swiss pharmaceutical company Basilea Pharmaceutica AG and Johnson & Johnson (J&J).

Ceftobiprole (ceftobiprole medocaril) is a novel cephalosporin antibiotic to treat complicated skin and skin structure infections, including diabetic foot infections. Ceftobiprole is designed for infections due to methicillin-resistant Staphylococcus aureus (MRSA) and hospital-acquired pneumonia, including ventilator-associated pneumonia due to suspected or proven MRSA. The NDA was submitted last May.

According to Basilea, FDA approval is subject to clinical study site inspections, the assessment of clinical and microbiological data “and further characterization of patients with diabetic foot infections.” The companies said they are reviewing the letter and intend to move quickly to address the agency’s questions. The product is being reviewed in the European Union, Switzerland and Canada.