FDA wants more test data on new liquid FluMist

By The Washington Post

Wednesday, July 19, 2006 2:12 AM CDT

WASHINGTON - MedImmune Inc. said Tuesday that the Food and Drug Administration wants more information about a new liquid formulation of the firm's nasal flu vaccine FluMist before making a decision on whether to let the company sell it.

The Gaithersburg, Md., biotechnology firm did not disclose the exact information sought by the FDA in a recent letter, but MedImmune spokeswoman Jamie Lacey said the agency's queries related to technical clarification of clinical and testing data already submitted.

MedImmune expects to respond in two to four weeks, Lacey said. MedImmune executives do not think the FDA's request would affect the chances of winning approval of the liquid formulation in time for the 2007-08 influenza season.

After a disastrous launch of FluMist in 2003, MedImmune has been aggressively pursuing a turnaround for the product.

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