FDA Expands Tamiflu Use for Influenza in Infants
The expanded approval is based on two open label safety and pharmacokinetic studies conducted in 136 infants <1 year of age infected with influenza. Based on these studies, a 3mg/kg dose of Tamiflu given twice daily for five days to infants is expected to have a similar safety and efficacy profile to that observed in older children and adults.
Tamiflu, a neuraminidase inhibitor, was originally indicated for the treatment of uncomplicated acute illness due to influenza infection in patients ≥1 year of age who have been symptomatic for ≤2 days, and for prophylaxis of influenza in patients ≥1 year of age.
For more information call (800) 821-8590 or visit www.tamiflu.com.