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Aug 16, 2013

GSK Wins FDA Approval for FluLaval Quadrivalent

  • GlaxoSmithKline (GSK) won FDA approval for its FluLaval® Quadrivalent influenza virus vaccine. The vaccine was approved for active immunization of patients ages three and older to help prevent disease caused by seasonal flu A and B strains.

    FluLaval Quadrivalent is designed to decrease flu-related morbidity across children, adults, and the elderly by protecting patients against the two A strains and two B strains that constitute the four primary influenza strains known to cause the majority of illness associated with the flu.

    The vaccine is the second GSK intramuscular quadrivalent flu vaccine approved by the FDA in less than a year. In December, the agency gave its approval to Fluarix Quadrivalent, the first-ever intramuscular influenza vaccine, which according to the company is shipping to customers.

    With the approval of FluLaval Quadrivalent, GSK said it anticipates the capacity to supply approximately 35 million doses of quadrivalent vaccine to the U.S. market for the upcoming 2014–15 flu season. However, GSK also said it will make “a limited amount” of FluLaval Quadrivalent available in time for the upcoming 2013–14 flu season. 

    GSK also said it plans to fulfill orders for Fluarix Quadrivalent, Fluarix Trivalent, and FluLaval Trivalent, the last of which was recently approved for expanded use in patients aged three years and above.

    FluLaval Quadrivalent will be available in multi-dose vials, the company said, allowing healthcare providers another administration format for quadrivalent vaccines to complement Fluarix Quadrivalent, which is available in prefilled syringes.

    GSK said that beginning in 2014 it will have the capacity to supply the United States “substantial quantities” of quadrivalent influenza vaccine shots manufactured in Quebec, Canada (FluLaval Quadrivalent), as well as in Dresden, Germany and Marietta, PA (Fluarix Quadrivalent).

    The FDA’s latest approval marks the first time that all GSK influenza vaccine shots have been approved for use by the FDA for children three years of age and older as well as for adults. FluLaval Trivalent vaccine had been previously limited for administration to individuals 18 and older.

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