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Published at www.nejm.org November 2, 2009 (10.1056/NEJMp0910479)

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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.

The legal standard for the authorization of an EUA during a declared public health emergency requires a finding that it is . . . [Full Text of this Article]

Source Information

From the Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.

This article (10.1056/NEJMp0910479) was published on November 2, 2009, at NEJM.org.

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