FDA Gives EUA for IV Peramivir
- By admin aapc
- In Coding
- November 2, 2009
- Comments Off on FDA Gives EUA for IV Peramivir
The U.S. Food and Drug Administration (FDA) announced Oct. 23, in response to a request from the U.S. Centers for Disease Control and Prevention (CDC), it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.
Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate, based on one or more of the following reasons:
- The patient is not responding to either oral or inhaled antiviral therapy, or
- When drug delivery by a route other than an intravenous route — e.g., enteral (absorbed by the intestines) or inhaled — is not expected to be dependable or feasible;
- For adults only, when the clinician judges IV therapy is appropriate due to other circumstances.
There are no FDA-approved intravenously administered antivirals for the treatment of influenza. Peramivir is the only intravenously administered influenza treatment currently authorized for use under EUA for 2009 H1N1 infections.
The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization is revoked by the agency.
Clinicians considering peramivir under EUA must read and understand the content of the FDA-issued Emergency Use Authorization of Peramivir IV: Fact Sheet For Health Care Providers prior to initiating a request and must agree to comply with terms and conditions of authorized use of peramivir per the FDA-issued EUA to successfully complete and transmit the request for this product.
For more information, go to the H1N1 Flu page on the CDC Web site, or call 1-800-CDC-INFO (1-800-232-4636).
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