ARTICLE | Clinical News

Ceftaroline acetate regulatory update

September 13, 2010 7:00 AM UTC

FDA's Anti-Infective Drugs Advisory Committee was unanimous that ceftaroline from Forest Labs was a safe and effective treatment for community-acquired bacterial pneumonia (CABP) and complicated skin and skin structure infections (cSSSIs). The panel voted 21-0 and 18-0, respectively.

Panel members were impressed by the robustness of the data for both indications. Ceftaroline met the prespecified primary endpoint of clinical response at time of cure, which was assessed 8-15 days after the last dose, for both indications. Ceftaroline also demonstrated a clinical response at day 4 for CABP and at day 3 for cSSSIs based on additional sensitivity analyses conducted by the agency. ...