FDA hits Basilea/J&J's ceftobiprole with complete response letter
This article was originally published in Scrip
Executive Summary
Just days after Basilea'santibiotic ceftobiprole received a CHMP positive opinion in the EU for the treatment of complicated skin and skin structure infections, the US FDA has issued it with a complete response letter, a setback that could by analysts' estimates delay the US launch by up to 12 months.