Product Information

• Package Insert - FluMist® Quadrivalent (PDF - 625KB)

Supporting Documents

• February 29, 2012 Approval Letter - FluMist® Quadrivalent
  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.
• Statistical Review and Evaluation - FluMist Quadrivalent (PDF - 106KB)
• Summary Basis for Regulatory Action - FluMist Quadrivalent (PDF - 129KB)
• Toxicology Review, January 29, 2012 - FluMist Quadrivalent (PDF - 235KB)
• Clinical Review, February 17, 2012 - FluMist Quadrivalent (PDF - 576KB)

Related Information

• FluMist
• Questions and Answers - FluMist Quadrivalent (Influenza Virus Vaccine Live, Intranasal)
• Press Release - FDA approves first quadrivalent vaccine to prevent seasonal influenza

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