Health

Advisory

PERAMIVIR EMERGENCY USE AUTHORIZATION FOR TREATMENT OF 2009 H1N1 INFLUENZA

The Food and Drug Administration (FDA) has issued an Emergency Use Authorized for the unapproved drug Peramivir, administered

intravenously to treat 2009 H1N1 Influenza. Peramivir is a neuraminidase inhibitor that is still in Phase 3 clinical trials. Peramivir is

authorized for patients admitted to the hospital under the care of a clinician skilled in the diagnosis and management of patients with

potentially life threatening illness and the ability to recognize and manage medication related adverse events. Peramivir is specifically

authorized for the treatment of adult and pediatric patients when IV therapy is appropriate, and the patient is not responding to either

oral or inhaled antiviral therapy drug delivery by a route other than intravenous and the clinician judges intravenous therapy for 2009

H1N1 Influenza is appropriate due to other circumstances. Peramivir is not authorized for the treatment of seasonal influenza A

or B virus infection, for outpatients with acute uncomplicated 2009 H1N1 Influenza virus infection or for pre or post exposure

chemoprophylaxis of influenza.

For additional information and to request Peramivir under the Emergency Use Authorization: http://www.cdc.gov/h1n1flu/eua/peramivir.htm

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