[kcimt_mag] Newest Update, You may have already seen this
- From: Monte Keady <MKeady@xxxxxxxxx>
- To: "kcimt_mag@xxxxxxxxxxxxx" <kcimt_mag@xxxxxxxxxxxxx>
- Date: Thu, 29 Oct 2009 09:19:46 -0700
FDA NOTE TO CORRESPONDENTS
For Immediate Release: Oct. 23, 2009
Media Inquires: Patricia El-Hinnawy, 301-796-4763;
patricia.el-hinnawy@xxxxxxxxxxx
Consumer Inquiries: 888- INFO-FDA
FDA Authorizes Emergency Use of Intravenous Antiviral Peramivir for 2009 H1N1
Influenza for Certain Patients, Settings
The U.S. Food and Drug Administration announced today that, in response to a
request from the U.S. Centers for Disease Control and Prevention, 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.
The FDA has reviewed the available scientific data and has concluded that the
criteria for authorizing the emergency use of IV peramivir have been met.
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.
For more information, see
http://kcfd1.kcfd1.com/exchweb/bin/redir.asp?URL=http://www.cdc.gov/h1n1flu/eua/
or call 1-800-CDC-INFO (1-800-232-4636).
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- » [kcimt_mag] Newest Update, You may have already seen this - Monte Keady
