Johnson & Johnson receives FDA approvable letter for ceftobiprole

Raritan, N.J. - Johnson & Johnson Pharmaceutical Research & Development has received a Food and Drug Administration (FDA) approvable letter for ceftobiprole, an antibiotic used to treat skin infections, according to an Associated Press report.

The Johnson & Johnson division, along with Switzerland-based partner Basilea Pharmaceutica Ltd., submitted a new-drug application to the FDA in May 2007 for ceftobiprole, which is used to treat disorders such as diabetic foot infections.

AP reports that the companies are reviewing the FDA letter, and will work to resolve any concerns the agency may have about ceftobiprole. Other applications for the drug are currently under regulatory review in Australia, Canada and some European countries.