Allergan announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the label for Teflaro (ceftaroline fosamil; Forest) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
The updated label includes new data from two ABSSSI trials that included patients with baseline Staphylococcus aureus bacteremia. Teflaro has also been approved for intravenous (IV) infusion in five minutes to 60 minutes in adults aged ≥18 years. Previously, Teflaro was approved for IV infusion over one hour.
The sNDA approval was based on data from two identical trials CANVAS 1 and 2 that compared ABSSSI patients treated with either Teflaro monotherapy or vancomycin plus aztreonam. Among the patients in the modified intent-to-treat (MITT) population (n=693), 20 patients had baseline S. aureus bacteremia. Out of the 20 patients, 13 (65%) achieved clinical response with Teflaro at Day 3 and, and 18 (90%) were considered clinical success at Test of Cure.
Teflaro for injection, a cephalosporin antibacterial, was initially approved by the FDA in 2010. It is available as 400mg and 600mg strength single-use vials in 10-count cartons.
For more information call (800) 678-1605 or visit Teflaro.com.