The Food and Drug Administration (FDA) has expanded the indication for Teflaro (ceftaroline fosamil; Allergan) to include treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth to less than 2 months of age.
Teflaro is now approved for use in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) for the treatment of ABSSSI caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.
Approval in this younger patient population for ABSSSI was supported by pharmacokinetic and safety data in 11 infants at least 34 weeks gestational age and 12 days postnatal age.
Teflaro, a cephalosporin antibiotic, is also indicated for the treatment of community-acquired bacterial pneumonia (CABP). The safety and effectiveness of Teflaro in pediatric patients below the age of 2 months for the treatment of CABP have not been established as no data are available.
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