FDA Approves Novartis’ New Seasonal Flu Vaccine
- By BSTQ Staff
Accelerated approval has been granted by the U.S. Food and Drug Administration for Novartis AG’s Agriflu to prevent disease caused by influenza virus subtypes A and B in adults ages 18 years and older. Because of the accelerated approval, Novartis is required to conduct additional studies to verify that Agriflu induces levels of antibodies in the blood that are effective in preventing seasonal flu.
The vaccine will be available in singledose, prefilled syringes that do not contain preservatives. The FDA noted that Agriflu is not intended to protect against the 2009 H1N1 influenza.
The Swiss drugmaker also markets another seasonal influenza vaccine in the U.S., Fluvirin, which is approved for people ages 4 years and older.