FDA Rejects Johnson & Johnson Skin Drug

Trenton, NJ (AHN) - Johnson & Johnson announced Wednesday the U.S. Food and Drug Administration rejected the application for its ceftobiprole drug, which treats skin infections as well as diabetic foot infections.

The FDA sent a letter asking Johnson & Johnson's Pharmaceutical R&D unit to conduct additional audit work of clinical investigator sites and address questions related to site monitoring.

J&J has been working in tandem with Basilea Pharmaceutica Ltd., a swiss company, on the development of the drug.

This is the second occasion the FDA had pushed back asking for further data. The companies applied for approval in the spring of 2007, but in March received a letter from the FDA seeking further studies.

The drug is already approved and marketed in Canada and Switzerland.

The European Union has recently received a recommendation for approval from its advisory committee for the treatment of skin infections.

Shares of J&J fell 0.7 percent to $58.27 in Wednesday trading.