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FDA Reviews Application for Intranasal Vaccine.(Brief Article)

Vaccine Weekly

| January 17, 2001 | COPYRIGHT 2001 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2001 JAN 17 - (NewsRx.com & NewsRx.net) -- Aviron (AVIR) announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for FluMist, an investigational intranasal influenza vaccine.

On October 31, 2000, Aviron submitted a BLA to the FDA seeking U.S. licensure of FluMist to prevent influenza in healthy children and healthy adults. The decision by the FDA to accept the submission for review was the next step in the regulatory process. If approved, FluMist would be the first flu vaccine delivered as a nasal mist to be commercially available in the U.S.

The BLA acceptance triggers a $15.5 million payment to Aviron from ...

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