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U.S. Department of Health and Human Services

BARDA FDA 50 Product Approvals - Alternative Text Description

#Medical CountermeasureThreat AreaCompany SponsorYear
1H5N1 vaccine Antigen-alone formulationInfluenzasanofi pasteur2007
2Fluzone® H1N1 influenza vaccine adultInfluenzasanofi pasteur2009
3Fluvirin® H1N1 influenza vaccineInfluenzaNovartis2009
4FluMist® H1N1 influenza vaccineInfluenzaMedImmune2009
5FluLaval® H1N1 influenza vaccineInfluenzaGlaxoSmithKline2009
6Afluria® H1N1 influenza vaccine infantsInfluenzaCommonwealth Serum Laboratories2009
7Afluria® H1N1 influenza vaccine adultInfluenzaCommonwealth Serum Laboratories2009
8XPERT FLU® H1N1 Influenza POC diagnosticInfluenzaCepheid2011
9LIAT®Influenza A/B Rapid diagnostic Influenza A/B Rapid diagnosticInfluenzaIquum / (Roche)2011
10Veritor® Influenza A/B Rapid diagnosticInfluenzaBecton Dickinson2012
11Simplexa® Point-of-care diagnostic deviceInfluenzaFocus/3M2012
12Flucelvax® Seasonal cell-based influenza vaccineInfluenzaNovartis2012
13Aura® Next generation portable ventilatorInfluenzaCovidien2012
14Raxibacumab® Anthrax antitoxinAnthraxGlaxoSmithKline (formerly HGS)2012
15FluBlØk® Seasonal recombinant-based influenza vaccineInfluenzaProtein Sciences2013
16HBAT Botulinum heptavalent antitoxinBotulismEmergent (formerly Cangene)2013
17Q-PAN® H5N1 Pandemic influenza vaccine with adjuvantInfluenzaGlaxoSmithKline2013
18Sophia® Influenza A/B Rapid diagnosticInfluenzaQuidel (Nanogen)2013
19PharmaJet Needleless Flu Shot StratisInfluenzaPharmaJet2014
20Rapivab® (peramivir) Influenza antiviral drug IVInfluenzaBioCryst2014
21Anthrasil™ (AIG) Anthrax antitoxinAnthraxCangene2015
22Neupogen® (filgrastrim) ARS anti-neutropenia cytokineRAD/NUCAmgen2015
23Neulasta (GM-CSFpeg) ARS anti-neutropenia cytokineRad/NucAmgen2015
24BioThrax® (post-exposure prophylaxis indication)AnthraxEmergent2015
25Fluad (with adjuvant) Influenza vaccine for seniorsInfluenzaSequris (CSL - Novartis)2015
26Anthim Anthrax MonoclonalAnthraxElusys2016
27Flucelvax Quadrivalent Influenza Virus VaccineInfluenzaSeqrius2016
28Flucelvax Quadrivalent Influenza Virus Vaccine (Pediatric Indication)InfluenzaSeqirus2016
29Q-Pan H5N1 AS03-Adjuvanted Pandemic Influenza Virus Vaccine for PediatricsInfluenzaGSK2016
30Flublok Quadrivalent Influenza Virus VaccineInfluenzaProtein Sciences Corporation2016
31Vabomere (Carbavance)BSAMEDCO2017
32Rapivab® (peramivir) Influenza antiviral drug IVInfluenzaBioCryst2017
33Cobas LIAT C. Diff POC diagnosticCBRNRoche2017
34Roche LightMix Zika Molecular DiagnosticZikaRoche2017
35Leukine® (sargramostim) ARS anti-neutropenia cytokineRAD/NUCsanofi aventis2018
36ZEMDRI PlazomicinBSAAchaogen2018
37Procleix Zika Virus AssayZikaHologic/Grifols2018
38Arestvyr®ST-246 (Tecovirimat) Smallpox antiviral drugSmallpoxSIGA2018
39XeravaBSATetraphase2018
40Flucelvax Process 3.0InfluenzaSeqirus2018
41SeizalamChemicalMeridian2018
42RECELLBurnAvita2018
43QMS Plazomicin ImmunoassayBSAAchaogen (Thermo Fisher)2018
44FluChip-8G Influenza A+B AssayInfluenzaInDevR2019
45 InBios International Manual Zika IgM assayZikaInBios2019
46ADVIA Centaur® Zika testZikaSiemens2019
47Trilogy Evo Universal (K181170) ventilatorInfluenzaPhillips2019
48SilverlonChemicalArgentum Medical2019
49IMVAMUNE® Smallpox MVA VaccineSmallpoxBavarian Nordic2019
50Applied Biosystems™ Bacillus anthracis Detection KitAnthraxApplied Biosystems2019
51OraQuick Ebola Rapid AntigenEbolaOraSure2019

  • This page last reviewed: October 11, 2019