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H1N1 vaccine: GSK waiting for approval from the United States

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The British pharmaceutical group GlaxoSmithKline (GSK) said Wednesday it was working to obtain "as soon as possible" approval for its vaccine against the H1N1 flu in the United States, where authorities on Tuesday approved four other companies.

  •     "GSK has submitted earlier this month a record to the FDA (Food and Drug Administration), for approval of its H1N1 vaccine," said the spokesman of the British group.

        The request is still pending, said the spokesman, but did not say when the American authorities could give the green light.

        "We work in close contact with the FDA to obtain approval as quickly as possible but we can not speculate about when this could happen," he said.

        The FDA gave the green light Tuesday to vaccines against H1N1 influenza produced by four laboratories: the Australian CSL Limited, MedImmune (subsidiary of AstraZeneca UK), Swiss Novartis and the French Sanofi Pasteur (The vaccines division of Sanofi - Aventis). The authority had added a fifth approval, requested by GSK, which was in study.
        
        
    Ennaharonline/ M. O.

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