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FDA Approves Roche (RHHBY)'s Tamiflu for Infants


12/27/2012 6:35:16 AM

The FDA recently expanded the approved use of oseltamivir phosphate to treat children older than 2 weeks who have exhibited symptoms of flu for no longer than 2 days. Oseltamivir (Tamiflu, Roche) has not been approved for prevention of flu infection in this population, however, and the safety and efficacy to treat flu infection has not been established in children younger than 2 weeks old. Oseltamivir was approved in 1999 to treat adults infected with flu who demonstrated symptoms for no longer than 2 days. It has since been approved to treat flu in children aged 1 year and older who have exhibited symptoms of flu for no longer than 2 days, and to prevent flu in adults and children aged 1 year and older. Although there is a fixed dosing regimen for patients aged 1 year and older according to weight categories, the dosing for younger children must be calculated individually based on their exact weight. Children should receive 3 mg per kg twice daily for 5 days, a dosage that will require a different dispenser than that currently co-packaged with oseltamivir.

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