Navigation Links
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:

  1. The patient is not responding to either oral or inhaled antiviral therapy, or
  2. 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;
  3. 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://emergency.cdc.gov/h1n1antivirals or call 1-800-CDC-INFO (1-800-232-4636).

Media Inquires: Patricia El-Hinnawy, 301-796-4763; patricia.el-hinnawy@fda.hhs.gov

Consumer Inquiries: 800-INFO-FDA

SOURCE U.S. Food and Drug Administration


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

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:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... 13, 2017 , ... Dickinson Insurance and Financial Services, a ... services, is providing an update on a charitable event that began earlier this ... a locally recognized nonprofit that provides shelter and care for animals seeking new ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... process to promote standards of excellence for the field of eating disorders, announces ... 22 – 25, 2018 in Orlando, Florida at the Omni Resort at ChampionsGate. ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , ... mock evacuation of the facility as part of a disaster drill on October 3rd. ... EMS and Shelton City Emergency Manager, as well as the Connecticut Long Term ...
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids ... sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited ... all ages; it is a non-competitive, non-timed event, which is all about having fun ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to the ... save lost souls in the Philippines. “The Journey: From the Mountains to the Mission ... of the Bible. She has taught all ages and currently teaches a class of ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... , Sept. 25, 2017   Montrium ... Master File solutions, today—from the IQPC Trial Master ... , NL)—announced that EastHORN Clinical Services has ... clinical programs and TMF management. EastHORN, a leading ... eTMF platform to increase transparency to enable greater ...
(Date:9/23/2017)... Pa. , Sept. 22, 2017 Janssen ... a complete response letter from the U.S. Food and ... seeking approval of sirukumab for the treatment of moderately ... letter indicates additional clinical data are needed to further ... moderately to severely active RA. ...
(Date:9/22/2017)... , Sept. 22, 2017 AVACEN Medical (AVACEN) ... is now successfully helping those with the widespread pain ... Fibromyalgia diagnosed Amanda in Essex, England ... washing my hair, experiencing no sleep at all, tremendous ... spasm… I cannot recommend [the AVACEN 100] enough, how ...
Breaking Medicine Technology: