Reasons for Relenza EUA Described for the General Public

• Relenza is an FDA-approved antiviral prescription drug for treatment of uncomplicated acute (mild) illness due to influenza A and B virus in people 7 years and older who have been symptomatic for no more than two days, and for prevention of influenza in people 5 years and older.
• A Public Health Emergency has been declared due to the outbreak of H1N1 Flu infections identified in the United States.
• The Acting Commissioner of the Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Relenza for use at later time points (i.e., in patients who are symptomatic for more than 2 days) and/or in patients sick enough to require hospitalization (severe illness).
• The EUA also authorizes Relenza to be accompanied by certain written emergency use information.
• During an emergency, normal prescribing and dispensing requirements may not be met for Relenza. Therefore, the EUA for Relenza also authorizes distribution or dispensing of Relenza without all of the FDA-required prescription label information (e.g., patient’s name, doctor’s name, and date of dispensing).
• FDA has authorized the use of certain expired Relenza product deployed from the Strategic National Stockpile (SNS) based on scientific review and analysis of available data. More information can be found at: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm154962.htm.
• The EUA also notes that public health officials or other volunteers may distribute Relenza to recipients in accordance with applicable state and local law and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction.