GlaxoSmithKline submits Biologics License Application for FDA approval of FluLaval

By Elaine Rigoli

Tampa, Fla., March 23 - GlaxoSmithKline has submitted a Biologics License Application to the Food and Drug Administration for FluLaval, intended for immunization against influenza disease caused by influenza virus types A and B, which are contained in the vaccine.

Following last year's approval of Fluarix, yesterday's announcement is another important step toward ensuring adequate availability of a critical weapon to fight the flu, officials said.

Fluarix (influenza virus vaccine) was approved by the FDA on Aug. 31, 2005.

GlaxoSmithKline added FluLaval to its portfolio of flu products when it acquired the Canadian vaccine manufacturer ID Biomedical Corp. in December.

FluLaval was granted fast track status by the FDA in July 2005 and is marketed in Canada under the name Fluviral, according to a news release.

If granted U.S. marketing approval for FluLaval, GlaxoSmithKline expects to provide up to 30 million doses of seasonal influenza vaccine (FluLaval and Fluarix) to the U.S. market for the 2006/2007 flu season, the release said.

GlaxoSmithKline is a research-based pharmaceutical and health care company with headquarters in Philadelphia.

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