Reuters: Regulatory News: U.S. FDA delays approval of GSK bird flu vaccine

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U.S. FDA delays approval of GSK bird flu vaccine Mar 25th 2013, 13:04 LONDON, March 25 | Mon Mar 25, 2013 9:04am EDT LONDON, March 25 (Reuters) - U.S. regulators have delayed approval of an H5N1 bird flu vaccine from GlaxoSmithKline , designed to be used in a pandemic. The vaccine had been backed by an expert panel in November but GSK said on Monday the Food and Drug Administration (FDA) had informed it that additional review time was needed before approval. Britain's biggest drugmaker said the delay was "due to an administrative matter that has recently been rectified", adding the company and the FDA were working to complete to review in a timely manner.

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