FDA Authorizes Emergency Use of Intravenous Antiviral Peramivir for 2009 H1N1 Influenza for Certain Patients... ( SILVER SPRING Md. Oct. 23 -- The U.S...)

FDA Authorizes Emergency Use of Intravenous Antiviral Peramivir for 2009 H1N1 Influenza for Certain Patients, Settings

Date:10/24/2009

SILVER SPRING, Md., Oct. 23 /PRNewswire-USNewswire/ -- 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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

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 au
'/>"/>

2

GOOD

Page: 1 2
Related medicine news :

1. Young Innovations, Inc. Board of Directors Declares Quarterly Dividend and Authorizes Share Repurchase Program
2. Syndication Inc. Board of Directors Authorizes the CEO to Rescind 300 Million Shares of the Companys Common Stock to Treasury
3. Quest Diagnostics Board Authorizes $500 Million in Share Repurchases
4. BD Board Declares Dividend Increase and Authorizes Additional Share Repurchases
5. Tianyin Pharmaceutical Co., Inc. Authorizes $3.0 Million Stock Repurchase Program
6. Young Innovations, Inc. Board of Directors Declares Quarterly Dividend, Authorizes Share Repurchase Program and Announces Election of New Officers
7. Brookdale Board of Directors Authorizes $150 Million Share Repurchase Program
8. Varian, Inc. Board Authorizes New $100 Million Stock Repurchase Program
9. Perrigo Company Authorizes Continuation of Share Repurchase Program and Announces Quarterly Dividend
10. Aflac Incorporated to Accelerate Share Repurchase in 2008; Authorizes Additional Share Repurchase and Increases Quarterly Cash Dividend 17.1%
11. QLT Board authorizes exploration of strategic alternatives to enhance near- to mid-term shareholder value

Post Your Comments:

FDA Authorizes Emergency Use of Intravenous Antiviral Peramivir for 2009 H1N1 Influenza for Certain Patients...( SILVER SPRING Md. Oct. 23 -- The U.S...),Health