FDA issue approvable letter to J&J on Ceftobiprole

Johnson & Johnson announced that it received an approvable letter from the USFDA regarding its New Drug Application (NDA) for Ceftobiprole (6R,7R)-7-[ [(2Z)-2-(5-amino-1,2,4-thiadiazol-3-ylidene)-2-nitroso-1-oxoethyl]amino]-8-oxo-3-[(E)-[2-oxo-1-[(3R)-3-pyrrolidinyl]-3-pyrrolidinylidene]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid) for the treatment of complicated skin and skin structure infections, including diabetic foot infections.
Ceftobiprole is a fifth generation cephalosporin antibiotic with activity against methicillin-resistant Staphylococcus aureus, penicillin-resistant Streptococcus pneumoniae and Enterococci. It was discovered by Basilea Pharmaceutica and was developed by Johnson & Johnson Pharmaceutical Research and Development. The drug is under regulatory review in Europe, Australia and Canada