Proper Name: Influenza Vaccine Live, Intranasal
Tradename: FluMist® Quadrivalent
Manufacturer: MedImmune, LLC
- For active immunization of individuals 2 through 49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
- July 15, 2019 Approval Letter - FluMist
- February 28, 2019 Approval Letter - FluMist Quadrivalent
To remove information from the Use in Specific Populations section of the Highlights of Prescribing Information of the package insert (PI) for clarity.
- August 10, 2018 Approval Letter - FluMist Quadrivalent
To include the 2018-2019 United States formulation and associated labeling revisions.
- May 15, 2018 Approval Letter - FluMist Quadrivalent
To revise package insert to comply with Pregnancy and Lactation Labeling Rule.
- March 17, 2017 Approval Letter - FluMist Quadrivalent
To revise the Ovalbumin test release specification and make the associated changes to the labeling.
- July 1, 2016 Approval Letter - FluMist
To include the 2016-2017 United States formulation and associated labeling revisions.
- February 13, 2015 Approval Letter - FluMist Quadrivalent
To revise labeling.
- Supporting Documents older than three years - FluMist Quadrivalent