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:5/25/2016)... -- According to market research "Global Insulin ... Forecast to 2022 - Industry Insights by Type (Insulin ... P&S Market Research, the global insulin delivery device market ... is expected to grow at a CAGR of 6.6% ... is expected to witness the fastest growth at a ...
(Date:5/25/2016)... England , May 25, 2016 ... company employing the precision of circulating tumour DNA ... today announces the appointment of Professor Clive ... provide medical leadership across the clinical development programme, ... Inivata,s products help deliver significant improvements in clinical ...
(Date:5/24/2016)... 24, 2016   , ... in overall bowel cleansing and superiority in ... leansing of the ascending ... , Norgine B.V. today announced new positive data from ... ascorbate bowel preparation) versus standard 2 litre PEG with ascorbate. The ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... There are nearly 14.5 million people living with ... worldwide. On Sunday, June 5, 2016, communities around the world will gather to recognize ... , National Cancer Survivors Day® is an annual worldwide Celebration of Life that is ...
(Date:5/26/2016)... ... May 26, 2016 , ... In an effort to provide hair restoration information to the ... users and those who do not use the app. Dr. Mohebi, the founder of Parsa ... Dr. Mohebi Live . , Dr. Mohebi says, “The positive response to the Snapchat ...
(Date:5/26/2016)... ... 26, 2016 , ... North Cypress Medical Center hosted its 9th ... Cypress. With the help of community partners, the event organizers raised $45,000 for the ... wounded service members and their families through health, wellness, and therapeutic support. , ...
(Date:5/26/2016)... ... May 26, 2016 , ... Power Systems, a ... first PowerWave Instructor Certification Course in Stoughton, Massachusetts. The course was led by ... through the 8 hour interactive course to qualify participants as certified PowerWave trainers. ...
(Date:5/26/2016)... ... May 26, 2016 , ... The introduction of our professional athletes coincides ... HEAD ™”. , “We are proud to introduce Meghan Klingenberg, defender and ... have Brian Quick, wide receiver for Los Angeles who was a second round selection ...
Breaking Medicine News(10 mins):