April 28, 2009
FDA authorizes emergency use of influenza medications, diagnostic tests in response to swine flu outbreak
Tamiflu is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients ≥1year of age who have been symptomatic for ≤2days and prophylaxis of influenza in patients ≥1year of age. The EUA will allow Tamiflu to be used for the treatment and prevention of influenza in children <1year of age and provide alternate dosing recommendations for children >1year of age.
Relenza is indicated for the treatment of uncomplicated acute illness due to influenza A and B virus in patients ≥7years of age who have been symptomatic for ≤2days and the prophylaxis of influenza in patients ≥5 years of age. Under the EUA, both Tamiflu and Relenza may be distributed to large segments of the population, without complying with the label requirements, and with written information pertaining to the emergency use. They may also be distributed by a broader range of healthcare workers, including some public health officials and volunteers, in accordance with applicable state and local laws and/or public health emergency responses.
For more information visit www.fda.gov/bbs/topics/NEWS/2009/NEW02002.html.