Johnson & Johnson Pharmaceutical Research & Development L.L.C., a division of Johnson & Johnson, said today that it has received a complete-response letter from the U.S. Food and Drug Administration regarding a drug for skin infections.
This marks the third time that the FDA is seeking more information on the drug.
This unit of Johnson & Johnson is based in Raritan, N.J.; Johnson & Johnson has other operations in the Philadelphia region.
The new-drug application had been submitted to the FDA in May 2007.
The FDA has requested more information and suggested that clinical studies be conducted on ceftobiprole, which also could be used to treat diabetic foot infections.
It was licensed from Swiss-based Basilea Pharmaceutica Ltd. in February 2005. J&JPRD received an approvable letter (the predecessor to the complete-response letter) in March 2008 and responded that August. A complete-response was issued in November 2008, and the company responded in June.
The drug is already approved in Canada, Switzerland, Russia, Azerbaijan, Ukraine and Hong Kong.