FDA Expands Tamiflu Use for Influenza in Infants

TAMIFLU (oseltamivir phosphate) 6mg oral suspension by Genentech
TAMIFLU (oseltamivir phosphate) 6mg oral suspension by Genentech

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.

For more information call (800) 821-8590 or visit www.tamiflu.com.