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Fridge-stable FluMist gets "complete response"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

MedImmune says it continues to expect its refrigerator-stable formulation of FluMist (intranasal influenza vaccine live) will reach the market in time for the 2007-2008 flu season after receiving a "complete response" letter July 18. FDA is requesting clarification and additional information on the new formulation, which the company submitted July 28. MedImmune is seeking approval to switch formulations from frozen FluMist, indicated in healthy individuals 5 to 49 years of age, to the refrigerator-stable cold adapted influenza vaccine, trivalent (CAIV-T). MedImmune announced July 31 that it has submitted a FluMist sBLA to expand the treatment population down to pediatrics in the 12 to 59-month age range...
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