MedImmune says FDA requests more FluMist data

By Elaine Rigoli

Tampa, Fla., July 18 - The Food and Drug Administration issued a complete response letter requesting clarification and additional information relating to MedImmune, Inc. data previously submitted for a new formulation of intranasal FluMist.

MedImmune is seeking approval to use refrigerator-stable cold adapted influenza vaccine in preventing influenza in healthy individuals between the ages of five and 49 years old.

The company said it will fully respond to the FDA within two to four weeks.

Additionally, MedImmune said that, within the next few weeks, the company will request an expanded label for FluMist in young children, based on data from a phase 3 study involving about 8,500 children between six months and 59 months of age.

Based in Gaithersburg, Md., MedImmune is focused on the areas of infectious diseases, cancer and inflammatory diseases.

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