Genentech announced that the FDA has expanded the approval of Tamiflu (oseltamivir phosphate) for the treatment of acute, uncomplicated influenza to include infants >2 weeks old.

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.

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