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Aviron FluMist "complete response"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA issues "complete response" letter for Aviron's Flumist for prevention of influenza in healthy children and adults. The letter, received by the firm Aug. 31, requests information "regarding clinical and manufacturing data." Aviron does not expect to conduct additional clinical trials and still expects a 2002 FluMist launch. During a July 30 analysts meeting, Aviron said the company will submit a pediatric safety study in Kaiser Permanente outpatients by the end of the year to FDA, and would be willing to "raise the lower age threshold for the indication" if it would hasten approval. At the Vaccines and Related Biological Products Advisory Committee review July 26-27, concern was expressed about the limited amount of data in children aged 12-15 months and about insufficient safety data
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