"Roche files supplemental new drug application to extend prophylaxis indication
for Tamiflu to patients between one to 12 years of age. Roche has filed a supplemental
new drug application (sNDA) with the U.S. Food and Drug Administration (FDA),
requesting an extension of the prophylaxis indication for Tamiflu (oseltamivir
phosphate) to include children ages one through 12. Currently, Tamiflu is indicated
for the prophylaxis of influenza in adult patients and adolescents 13 years and
older. Tamiflu is also indicated for the treatment of uncomplicated acute illness
due to influenza type A or type B infection in patients one year and older who
have been symptomatic for no more than two days. Roche is optimistic that FDA
will complete their review of the sNDA before the next flu season." Tamiflu drug
is available for shipment worldwide.
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