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GSK Fluarix submission

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GlaxoSmithKline anticipates an expedited review for its influenza vaccine Fluarix; the company submitted a BLA May 25. GSK has begun a manufacturing ramp-up aimed at providing 10 mil. doses of the vaccine for the 2005-06 flu season. Competitor Chiron, whose Fluvirin was removed from the market last season due to manufacturing issues, expects to begin shipping 25 mil. to 30 mil. doses of its product in the third quarter; the firm said FDA is slated to inspect its manufacturing facility in mid-June to late July...
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