2009 Nov 2 – The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza

Debra Birnkrant, M.D., and Edward Cox, M.D., M.P.H. Published at www.nejm.org November 2, 2009
On October 23, 2009, Food and Drug Administration (FDA) Commissioner Margaret Hamburg issued an Emergency Use Authorization (EUA) for peramivir for intravenous injection (BioCryst Pharmaceuticals). Peramivir is an unapproved investigational neuraminidase inhibitor that may be effective in treating certain hospitalized adult and pediatric patients with suspected or confirmed cases of 2009 H1N1 influenza. The EUA allows health care providers to use peramivir, subject to specified conditions. This is the first EUA that has been issued for an unapproved drug.


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