Navigation Links
FDA Approves Agriflu Seasonal Influenza Vaccine
Date:11/27/2009

Another option to prevent illnesses caused by subtypes A and B influenza virus

SILVER SPRING, Md., Nov. 27 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

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

Agriflu, manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, was approved using the FDA's accelerated approval pathway, which helps safe and effective medical products for serious or life-threatening diseases become available sooner. In this case, Novartis demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.

Agriflu is administered as a single injection in the upper arm and is available in single dose, pre-filled syringes that do not contain preservatives.

"The approval of the new seasonal influenza vaccine, Agriflu, is an important step in adding to the production capacity to enhance the supply of vaccine for the United States for future influenza seasons," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.

Common side effects in clinical studies included pain, swelling and redness at the injection site, headache, muscle aches and malaise. People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

As part of the accelerated approval process, Novartis is required to conduct further studies to verify that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza. The company also manufactures another licensed seasonal influenza vaccine, Fluvirin, for use in the United States. Fluvirin is approved for people ages 4 years and older. Agriflu is not intended to protect against the 2009 H1N1 influenza.

For more information, visit FDA's Webpage on 2009 - 2010 Season Flu Vaccines at:

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm100139.htm

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


'/>"/>
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lysteda to Treat Heavy Menstrual Bleeding
2. Rogan-Delft Approves Matrox Xenia Series for Use With Zillion Suite
3. FDA approves GlaxoSmithKlines VOTRIENT(TM) for advanced renal cell cancer
4. FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use
5. FDA Approves New Treatment for Advanced Form of Kidney Cancer
6. FDA Approves Elitek(R) (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy
7. FDA Approves Cervarix, GlaxoSmithKlines Cervical Cancer Vaccine
8. U.S. Food and Drug Administration Approves CRESTOR(R) for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia
9. Chinese Food and Drug Administration Approves Gabexate Mesylate as Pharmaceutical Raw Material
10. FDA Approves New Indication For Mirena(R) to Treat Heavy Menstrual Bleeding in IUD Users
11. US FDA Approves Extavia(R) - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with this Devastating Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... Oct. 10, 2017  NDS received FDA 510(k) clearance in May ... battery-powered display stand specifically designed for endoscopy environments. An innovative secondary ... a clinical solution to support the improvement of patient outcomes, procedural ... ... ...
(Date:10/4/2017)... South Korea , Oct. 4, 2017  South ... its next-generation CPR training aide "cprCUBE" on Kickstarter. The ... chest compression during cardiac arrests with better efficiency compared ... It also offers real-time feedback on efficacy of the ... The crowdfunding campaign has a goal to raise $5,000. ...
(Date:10/2/2017)... 2, 2017  Eli Lilly and Company (NYSE: ... the third quarter of 2017 on Tuesday, October 24, ... that day with the investment community and media to ... conference call will begin at 9 a.m. Eastern time. ... live webcast of the conference call through a link ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to ... to save lost souls in the Philippines. “The Journey: From the Mountains to the ... teacher of the Bible. She has taught all ages and currently teaches a class ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... Planet Fitness, ... the U.S., announced today its plans to open a flagship location in Covington, LA ... the former Rooms To Go store next to Office Depot in the Holiday Square ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a ... health care, have expanded their existing home health joint venture through an agreement, ... been operating a joint venture home health company with Asante, delivering clinically integrated ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at Children’s ... the 49th Congress of the International Society of Paediatric Oncology (SIOP) Oct. ... Center for Cancer and Blood Disorders at Children’s National, and Stephen P. Hunger, ...
(Date:10/12/2017)... ... October 12, 2017 , ... In the United States, single-family ... some states—like New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, and California—the average ... extremely low property-tax rates, which contributes to the relatively lower cost of living ...
Breaking Medicine News(10 mins):