FDA Accepts sNDA to Expand Indication of Antibiotic Teflaro

Actavis Plc Feb. 4 announced that the Food and Drug Administration has accepted for filing its supplemental new drug application (sNDA) for Teflaro (ceftaroline-fosamil).

The company is seeking approval of Teflaro to treat cases of concurrent bacteremia in patients with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible isolates of Staphylococcus aureus (including Methicillin-susceptible and resistant isolates).

Concurrent bacteremia is a secondary infection that occurs when bacteria spreads from the primary site of infection to the blood stream, the Dublin-based company said. Concurrent bacteremia complicates infection treatment and in the most serious cases can be fatal.

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