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This release was revised on November 30, 2009 to include changes in the sixth paragraph.

FDA NEWS RELEASE

For Immediate Release: November 27, 2009

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves Agriflu Seasonal Influenza Vaccine
Another option to prevent illnesses caused by subtypes A and B influenza virus

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.

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.

Novartis is required to conduct further studies to verify that the vaccine will decrease seasonal influenza disease after vaccination.

The company also manufactures another licensed seasonal influenza vaccine, Fluvirin, for use in the United States. Fluvirinis 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  

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