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MedImmune FluMist "complete response"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

MedImmune plans to respond to its second "complete response" letter for FluMist before the end of August. The July 10 letter raises 24 manufacturing questions and 44 clinical questions relating to the influenza vaccine, including the issue of exacerbated rates of asthma and wheezing in patients 18 to 35 months of age. MedImmune is considering excluding the subpopulation from the indication as one way to address the problem, the company told a July 11 conference call. Increased reactogenicity in asthmatics was raised as an issue during a July 2001 advisory committee review. MedImmune does not expect to launch FluMist in time for the 2002 flu seaso

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