Archive for December 1st, 2008

FDA Issues Complete Response Letter for Ceftobiprole for Treatment of Complicated Skin Infections

Monday, December 1st, 2008

RARITAN, N.J., November 26, 2008 /PRNewswire/ — Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ceftobiprole for the treatment of complicated skin and skin structure infections, including diabetic foot infections.

The FDA has indicated that they cannot approv…