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news.US regulators have awarded Fluviral, ID Biomedical's developmental flu vaccine, fast track designation. With an accelerated review process, ID Biomedical hopes to secure FDA approval by April, 2006.
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The FDA is keen to encourage the development of other flu vaccines after suffering from supply shortages last year as a result of manufacturing problems at a Chiron Corporation facility based in the UK.
ID Biomedical indicated its expectation to have Fluviral ready to supply the US market in time for the 2006-07 flu season. The company also said that it would increase its 2007 production capacity at its two flu vaccine production facilities located in Laval and Quebec City, Quebec.
The Canadian-based biotech firm expects that with the US regulatory approval of its injectable flu vaccine and a successful pre-approval inspection of its facilities, the company will be able to produce approximately 20-25 million doses of influenza vaccine for the U.S. market in 2006, and approximately 40 million doses in 2007.