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:9/25/2017)... , Sept. 25, 2017   Montrium , ... File solutions, today—from the IQPC Trial Master Files ... , NL)—announced that EastHORN Clinical Services has selected ... programs and TMF management. EastHORN, a leading European ... platform to increase transparency to enable greater collaboration ...
(Date:9/22/2017)... DIEGO , Sept. 22, 2017 AVACEN ... medical device is now successfully helping those with the ... Fibromyalgia diagnosed Amanda in Essex, ... dressed and washing my hair, experiencing no sleep at ... in painful spasm… I cannot recommend [the AVACEN 100] ...
(Date:9/18/2017)... , Sept. 18, 2017 ... fields of bioinformatics and immune engineering, today ... protective avian influenza A (H7N9) vaccine. ... related to seasonal influenza and presents a ... on prior exposure to be effective. Using ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ProVest Insurance Group, ... Dallas, Miami, and Raleigh regions, is organizing an extended charity drive to benefit ... deadly chromosome abnormality. , After struggling since birth with several health challenges, T.J. ...
(Date:10/13/2017)... ... ... As health professionals work to improve their approach to healthcare, there is ... than filling out a survey; in many cases health professionals and patients are working ... and research on the importance of active engagement with patients and members of the ...
(Date:10/13/2017)... LEXINGTON, Ky. (PRWEB) , ... October 13, 2017 , ... ... MD, MPH to become its next President and Chief Executive Officer, succeeding Dr. James ... and CEO Elect beginning July 1, 2018 until Dr. Puffer’s retirement at the end ...
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading Health and Nutrition ... the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly growing CBD market ... can be easily incorporated into liquid products, while reducing costs to end users. , ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Lori R. ... a member of ElderCounsel, a national organization of elder law and special needs planning ... laws and rules. It also provides a forum to network with elder law attorneys ...
Breaking Medicine News(10 mins):