FDA approves label update for Teflaro (ceftaroline fosamil) in acute bacterial skin and skin structure infections- Allergan

Allergan announced the FDA has approved the company's supplemental new drug application (sNDA) to update the label for Teflaro (ceftaroline fosamil, Zinforo) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The approved label contains new clinical data from two ABSSSI trials that included patients with baseline Staphylococcus aureus bacteremia. Bacteremia complicates infection treatment and, in the most serious cases, can be fatal.

Teflaro is indicated for the treatment of ABSSSI caused by susceptible bacterial isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and -resistant isolates) Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae and Klebsiella oxytoca.

Comment: Teflaro was first approved by the U.S. FDA in October 2010 for the treatment of adults with CABP and ABSSSI due to designated susceptible pathogens. It is approved by the EMA as Zinforo.