MedImmune FluMist complete response
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
MedImmune submits FluMist "complete response" Aug. 26 to FDA's second action letter for the nasal flu vaccine, dated July 10 (Pharmaceutical Approvals Monthly, August 2002, In Brief). Wyeth has begun producing 4 mil. doses of FluMist in hopes of launching for the 2002 flu season; the doses will not be valid for the 2003 flu season. MedImmune says a 2002 launch would be "tight," as approval would be needed by Sept.
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