GSK Gets Approval for H1N1 sBLA

GlaxoSmithKline received approval from the FDA for its sBLA for unadjuvanted influenza A (H1N1) pandemic vaccine.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GlaxoSmithKline received approval from the FDA for its sBLA for unadjuvanted influenza A (H1N1) pandemic vaccine. The approval, which was filed as a strain change supplement to GSK’s FluLaval seasonal flu vaccine, allows the company to manufacture a flu vaccine for use in adults to prevent the 2009 pandemic H1N1 influenza A strain. The United States Department of Health and Human Services has placed an order to fill 7.6 million doses of the vaccine.The vaccine will be produced in multi-dose v...

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