*Safety and effectiveness for the treatment of influenza have been established in adults and pediatric patients 12 years and older weighing at least 40 kg. *Safety and effectiveness have not been established in pediatric patients less than 12 years. *Use in pediatric patients 12 years and older weighing at least 40 kg is supported by one randomized, double-blind, controlled trial in which 118 adolescents were randomized to receive either Xofluza (N=80) or placebo (N=38). The median time to alleviation of symptoms in adolescent subjects was 54 hours compared to 93 hours for subjects who received placebo. *Adverse reactions reported in adolescents were similar to those reported in adults. *Information on dosing, adverse reactions, clinical trial and PK parameters in adults and pediatric patients 12 years and older. *New drug.
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