FDA Authorizes Emergency Use of Intravenous Antiviral Peramivir for 2009 H1N1 Influenza
On October 23, 2009, the Commissioner of the Food and Drug Administration (FDA) issued an Emergency Use Authorization for the unapproved drug Peramivir IV to treat certain hospitalized adult and pediatric patients with suspected or laboratory confirmed 2009 H1N1 infection or infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology.
For complete information regarding the drug and the specific conditions of authorization for health care providers, please visit the FDA Peramivir Information page.
Your policy with The Doctors Company will respond to claims related to the use of Peramivir IV to treat H1N1 influenza when used in accordance with the FDA’s emergency authorization. No special endorsement or changes are necessary for you to receive these benefits. It is imperative that you become familiar with the FDA requirements and adhere to them strictly.
Read our Alert “Preparing Your Medical Practice for the Swine Flu (H1N1).”
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.