Reasons for Emergency Use Authorization of Tamiflu and Relenza

This website is archived for historical purposes and is no longer being maintained or updated. For updated information on the 2011-2012 flu season, see the CDC Seasonal Flu website.

April 29, 2009, 1:45 AM ET

Tamiflu and Relenza are both FDA-approved antiviral drugs that fight against the current swine influenza A (H1N1) virus.

Tamiflu is FDA-approved to treat and prevent influenza in people one year of age and older. Relenza is FDA-approved for treatment of influenza in people 7 years and older and for prevention of influenza in people 5 years and older.

A Public Health Emergency has been declared due to the outbreak of swine influenza A (H1N1) infections identified in the United States and abroad.

During an emergency, normal prescribing and dispensing requirements may not be met for Tamiflu and Relenza. Therefore, the Commissioner of the Food and Drug Administration (FDA) has authorized the emergency use of Tamiflu under an Emergency Use Authorization (EUA) for the following reasons:

To allow for dispensing of these antiviral drugs to patients without all of the FDA-required information on typical prescription labels (e.g. patient’s name, doctor’s name, and date of dispensing),
to allow for designated public health officials to distribute antiviral drugs during an emergency when there are shortages of doctors, nurses, and pharmacists,
to allow for distribution of antiviral drugs that have had the original manufacturer’s expiration dating extended by FDA, and
to be able to treat and prevent swine influenza A in infants and children younger than the FDA-approved ages (less than 1 year of age for Tamiflu).

An EUA is necessary for Relenza for reasons 1 and 2 listed above.