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MedImmune FluMist “complete response”

Executive Summary

MedImmune issues response to third "complete response" letter for intranasal flu vaccine FluMist Feb. 7. FDA outlined five questions in its Jan. 29 letter: one labeling clarification; three technical clarifications; and a fifth question on postmarketing studies. FluMist, which is co-developed with Wyeth, has been under review since October 2000. FDA's Vaccine & Related Biological Products Advisory Committee recommended approval for healthy patients between five and 49 years of age (1"The Pink Sheet" Dec. 23, 2002, p. 23). MedImmune expects a second quarter approval...
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