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U.S. FDA Approves GlaxoSmithKline Flu Vaccine
Escrito por Reuters   
01.09.2005
WASHINGTON (Reuters) Aug 31 - The U.S. Food and Drug Administration on Wednesday said it approved GlaxoSmithKline Plc's influenza vaccine Fluarix, just weeks before the start of the 2005-2006 U.S. flu season.

U.S. health officials said the approval should ease supply problems after last season, when one of two flu vaccine makers lost its license to produce the drug.

"Having more manufacturers of influenza vaccine licensed in the U.S., and having more vaccine dosages, is critical to public health," Health and Human Services Secretary Mike Leavitt said in a statement.

GlaxoSmithKline's vaccine, made by its German subsidiary Sachsisches Serumwerk, is cleared for use in adults, the FDA said.

Agency officials reviewed Glaxo's bid to sell its vaccine on an "accelerated" basis in hopes of filling the gap left when Chiron Corp. lost its license and could not deliver 48 million doses -- half the anticipated supply.

On Wednesday, the FDA said Chiron had taken steps to fix its problems, but that more work needed to be done for the company to rejoin Sanofi-Aventis unit Sanofi-Pasteur on the U.S. market this year.

MedImmune Inc. makes a nasal spray vaccine.

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