FDA News

MedImmune Resolves FDA Observations Regarding Manufacturing Process for FluMist

(Sept 09, 2007)-- MedImmune announced that it has resolved the observations made by the U.S. Food and Drug Administration (FDA) during an annual inspection of the company's influenza vaccine manufacturing facility in Speke, United Kingdom. The agency's observations led to the issuance of a Warning Letter on May 24, 2007, which has now been resolved. The UK facility is the bulk manufacturing site for FluMist(R) (Influenza Virus Vaccine Live, Intranasal). MedImmune will continue to work with the FDA on the implementation and ongoing execution of all quality and compliance commitments.

MedImmune is currently working with the FDA on the standard annual lot release process so that shipping of FluMist to customers can soon begin for the upcoming influenza season. MedImmune can now also take the necessary regulatory steps to seek the FDA's final approval of the company's supplemental biologics licensing application requesting expansion of the vaccine's indication to include children below 5 years of age.

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