FDA C'tee OKs Roche's Rocephin

A US Food and Drug Administration advisory committee has recommendedthe approval of Hoffmann-La Roche's Rocephin (sterile ceftriaxone sodium for injection), for the treatment of acute bacterial otitis media.

Clinical trials involving 2,450 children have demonstrated that the drug, when administered intramuscularly as a single dose, is comparable to standard 10-day multiple-dose oral treatments for this indication. In bacteriologic trials, Rocephin was 100% effective in eradicating Hemophilus influenzae, Moraxella catarrhalis and susceptible Streptococcus pneumoniae, the three most common causes of acute bacterial otitis media.