Genentech Announces FDA Approval of Tamiflu for the Treatment of Influenza in Infants

Genentech Press Release (12/21/12)
The Food and Drug Administration has approved Tamiflu for use in treating infants aged two weeks and up who have acute, uncomplicated influenza. The FDA's decision was based on two open label safety and pharmacokinetic studies that showed that giving infants a 3 mg/kg dose of Tamiflu twice a day for five days would likely have a safety and efficacy profile that is similar to what is seen in older children and adults who are treated with the drug. In addition, the studies showed that the safety profile in infants under one year was consistent with what was observed in other populations. The FDA's decision means that Tamiflu is now the only prescription antiviral medicine that is approved to treat flu patients of all ages.

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