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FDA

Official Releases

Food and Drug Administration

FDA expands licensure of FluLaval Quadrivalent to include people ages 6 through 35 months
FDA Approval - 11/18/16
FDA approves Flublok Quadrivalent (Protein Sciences) for use in persons 18 years and older
FDA Approval - 10/7/16
FDA expands licensure of Gardasil 9 to include a 2-dose regimen for individuals 9 through 14 years of age
FDA Approval - 10/7/16
FDA expands licensure for Prevar 13 to include people ages 18 through 49 years
FDA Approval - 7/11/16
FDA approves Vaxchora, a live oral vaccine to prevent cholera for adult travelers
FDA Approval - 6/10/16
FDA expands licensure of Trumenba MenB vaccine (Pfizer) administration to include 2-dose schedule and modification of the 3-dose schedule
FDA approval - 4/14/16
FDA expands licensure of Hiberix to include children ages 6 weeks through 4 years
FDA approval - 1/14/16
FDA expands Gardasil 9 licensure to include males age 16–26 years
FDA approval - 12/14/15
FDA licenses Fluad, injectable influenza vaccine (adjuvanted), for people age 65 years and older
FDA approval - 11/24/15
Two FDA CBER Mini-Sentinel Studies Completed on the Safety of Gardasil and Rotavirus Vaccines
FDA CBER - 4/23/15
Recall of Flulaval Quadrivalent
FDA recall notice - 4/15/15
FDA approves Quadracel (DTaP-IPV vaccine; Sanofi Pasteur) for use in children age 4 through 6 years
FDA approval - 3/25/15
FDA approves change in diluent storage temperature for Rotarix vaccine
FDA approval - 2/27/15
FDA Approves a Second Vaccine to Prevent Serogroup B Meningococcal Disease
FDA News Release - 1/23/15
Official Releases
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This page was updated on November 26, 2016.
This page was reviewed on March 31, 2016.
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This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 6NH23IP22550) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.