FDA Alerts
First Flu Vaccine with Adjuvant Approved
The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant.
FDA Approves First Adjuvanted Vaccine for Prevention of Bird Flu
The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu.
FDA approves new seasonal influenza vaccine made using novel technology
The US Food and Drug Administration today announced that it has approved Flublok , the first trivalent influenza vaccine made using an insect virus ( baculovirus ) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age.
FDA expands Tamiflu’s use to treat children younger than 1 year
The US Food and Drug Administration today expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days.
FDA approves first seasonal influenza vaccine manufactured using cell culture technology
The US Food and Drug Administration announced today the approval of Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs.
Novel Vaccine to Prevent Seasonal Influenza Approved
FluMist Quadrivalent , a vaccine to prevent seasonal influenza in people ages 2 years through 49 years, has been approved by the U.S. Food and Drug Administration.
FDA Approves Vaccines For The 2011-2012 Influenza Season
The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United States.
FDA Drug Safety Communication: Tamiflu
The U.S. Food and Drug Administration (FDA) is informing the public of important product safety changes to the influenza drug Tamiflu ( oseltamivir phosphate) for oral suspension.