The FDA, in response to requests from the CDC, has issued Emergency Use Authorizations (EUAs) to make diagnostic and therapeutic tools, including the rRT-PCR Swine Flu Panel and Tamiflu (oseltamivir, from Roche) and Relenza (zanamivir, from GlaxoSmithKline) antiviral products, available to public health and medical workers to identify and respond to the swine flu virus under certain circumstances. The EUA authority also allows the FDA to authorize the use of unapproved drugs or unapproved uses of approved drugs following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or authorization revoked by the FDA.
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.