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FDA accepts Actavis' supplemental NDA for Teflaro expanded labeling
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Actavis announced that the FDA has accepted a supplemental new drug application for the label expansion of Teflaro for the treatment of concurrent bacteremia in patients with acute bacterial skin and skin structure infections caused by susceptible isolates of Staphyloccus aureus.
The application was based on data from the CANVAS 1 and 2 trials, in which Teflaro (ceftaroline-fosamil) monotherapy was compared with vancomycin plus aztreonam for the treatment of patients with acute bacterial skin and skin structure infection (ABSSSI), according to a press release.
The broad-spectrum bactericidal cephalosporin, with activity against both gram-positive and gram negative pathogens, is indicated for the treatment of community-acquired bacterial pneumonia, including cases caused by Streptoccucus pneumoniae bacteremia, and ABSSSI, including cases caused by methicillin-resistant S. aureus, according to the release.
Researchers evaluated clinical response at test of cure (TOC) and day 3 of the study in patients who had S. aureus bacteremia at baseline in the microbiological-modified intent-to-treat population. Patients treated with ceftaroline-fosamil showed a comparable response of 90% at TOC and a higher response at study day 3 (65%) when compared with the vancomycin/aztreonam treatment cohort.
The FDA has a target of the third quarter of 2015 to complete its review of the label expansion, according to the release.
Reference: www.actavis.com.