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:4/29/2016)... ... ... On Tuesday, April 26, 2016 members of the HomeTown Health network, a ... Deal on SB 258, the “Rural Health Care Relief” Bill. , The bill, which ... to individuals and corporations which donate directly to a “rural hospital” in Georgia, and ...
(Date:4/29/2016)... ... April 29, 2016 , ... The White House ... their loans, more information about their loan terms and accounts, and more protections ... debt, including federal and private loans, has reached $1.3 trillion, with 43 million ...
(Date:4/29/2016)... ... April 29, 2016 , ... A ... born with severe congenital diaphragmatic hernia have better survival rates if surgery is ... hernia (CDH)—a condition where the diaphragm fails to form completely, letting abdominal organs ...
(Date:4/29/2016)... ... 2016 , ... Mobility Designed is redefining mobility with their patent pending ... Crutch evenly distributes body weight from the elbow to the forearm. In consumer ... than with other crutches. , Co-founders Max and Liliana Younger were inspired to design ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... Melanoma is the deadliest type of skin ... blame for the majority of skin cancer deaths. More than 10,000 people are expected to ... at diagnosis is 62, it is the one of the most commonly diagnosed cancers in ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)... , April 28, 2016 Oramed Pharmaceuticals ... clinical-stage pharmaceutical company focused on the development of oral drug ... the upcoming PIONEERS 2016 conference, presented by Joseph Gunnar ... in New York . Nadav Kidron ... the conference. Presentation Details:   ...
(Date:4/28/2016)... New market research titled ... report that provides an overview of the Osteoarthritis,s ... identifying new targets and MOAs to produce first-in-class ... in this H1 2016 Osteoarthritis Pipeline report include ... Abiogen Pharma S.p.A., Ablynx NV, Achelios Therapeutics, Inc., ...
(Date:4/27/2016)... , April 27, 2016   ... 42% Growth in Recurring Consumable Sales  Clinical ... Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) inventor of ... its sales for the first quarter ended March 31, ... the execution of its commercial strategy. First ...
Breaking Medicine Technology: