FDA issues approvable letter to J&J for ceftobiprole

RARITAN, N.J. The Food and Drug Administration has sent Johnson & Johnson Pharmaceutical Research & Development an approvable letter regarding a drug application the company submitted for its drug ceftobiprole.

The drug is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

Johnson & Johnson and its co-development partner Basilea Pharmaceutica submitted the application last May to the FDA and is reviewing the letter and working quickly to resolve any issues.