FDA warns Johnson & Johnson over ceftobiprole studies
The US Food and Drug Administration (FDA) has sent a warning letter to Johnson & Johnson relating to two clinical trials for ceftobiprole for the treatment of complicated skin and skin structure infections.
The US Food and Drug Administration (FDA) has sent a warning letter to Johnson & Johnson relating to two clinical trials for ceftobiprole for the treatment of complicated skin and skin structure infections.
The FDA cited "objectionable conditions" that included a failure to ensure proper monitoring of the studies as well as deficiencies in the study conduct.
"We conclude that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations," the FDA said in a letter to Johnson & Johnson Pharmaceutical Research and Development.
Ceftobiprole, an anti-MRSA broad-spectrum cephalosporin antibiotic, is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica in Switzerland and Cilag International, a Johnson & Johnson company.
The drug is marketed in Canada (Zeftera) for the treatment of complicated skin and skin structure infections (cSSSI), including non-limb threatening diabetic foot infections without concomitant osteomyelitis and in Switzerland (Zevtera) for the treatment of complicated skin and soft tissue infections (cSSTI) including diabetic foot infections without concomitant osteomyelitis.