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MCMi FY 2013: Appendix 1 - FY 2013 Medical Countermeasure Approvals

FDA MCMi Fiscal Year 2013 Program Update

 

Previous section: FY 2013 Objectives, Activities, and Achievements

 

Appendix 1 - FY 2013 Medical Countermeasure Approvals

Biologics

Drugs

Devices

 

FY 2013 Medical Countermeasure Approvals - Biologics

 

 Medical Countermeasure Sponsor/Applicant Key Dates Indication
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) (Equine) (BAT)
 
Cangene Corporation
  • Received 09/20/2012
  • Approved 03/22/2013
Approved for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients
 
Flucelvax
 
Novartis Vaccines and Diagnostics, Inc.
  • Received 02/26/2009
  • Withdrawn 04/27/2009
  • Resubmitted 11/22/2011
  • Approved 11/20/2012
Approved for the active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine in persons 18 years of age and older
Flublok Protein Sciences Corporation
  • Received 04/18/2008
  • Complete Response Letter Issued 08/29/2008
  • Resubmitted 04/27/2009
  • Complete Response Letter Issued 01/11/2010
  • Resubmitted 07/16/2012
  • Approved 01/16/2013
Approved for the active immunization against disease caused by influenza virus subtypes A and type B contained in the vaccine in persons 18 through 49 years of age
Fluarix Quadrivalent
 
GlaxoSmithKline Biologicals
  • Received 02/14/2012
  • Approved 12/14/2012
Approved for the active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine in persons 3 years of age and older
Fluzone Quadrivalent
 
Sanofi Pasteur, Inc.
  • Received 08/10/2012
  • Approved 06/07/2013
Approved for the active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine in persons 6 months of age and older
FluLaval Quadrivalent  ID Biomedical Corporation
  • Received 10/16/2012
  • Approved 08/15/2013
Approved for the active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine in persons 3 years of age and older

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FY 2013 Medical Countermeasure Approvals - Drugs

Medical Countermeasure Sponsor/Applicant Key Dates Indication
Raxibacumab  GlaxoSmithKline
  • Received 05/14/2009
  • Complete Response Letter Issued 11/14/2009
  • Resubmitted 06/15/2012
  • Approved 12/14/2012
Approved to treat adult and pediatric patients with inhalational anthrax in combination with appropriate antibacterial drugs and to prevent inhalational anthrax when alternative therapies are not available or not appropriate
Tamiflu (oseltamivir) Hoffmann-La Roche, Inc.
  • Received 06/21/2012
  • Approved 12/21/2012
Expanded approval for use of Tamiflu to treat children as young as 2 weeks old (previously approved for ages 1 year and older)

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FY 2013 Medical Countermeasure Approvals - Devices

 Medical Countermeasure Sponsor/Applicant Key Dates Indication
 Aura Ventilator Newport Medical Instruments, Inc.
  • Received 06/29/2012
  • Approved 11/09/2012
Approved to provide ventilatory support for infant, pediatric and adult patients in hospital, sub-acute, emergency response, transport and homecare environments under the direction of a physician
Burn Resuscitation Decision Support System (BRDSS)  Arcos, Inc.
  • Received 06/05/2012
  • Approved 04/18/2013
Approved for use in the care of adult patients with 20% or more Total Body Surface Area (TBSA) burned as a fluid resuscitation calculator for hourly fluid recommendations
 
JBAIDs Anthrax Detection Kit BioFire Diagnostics, Inc.
  • Received 06/28/2013
  • Approved 08/05/2013
Modified the previously approved JBAIDS Anthrax Detection Kit for use with the IT
1-2-3"1Platinum Path Sample Purification Kit Accessory for the qualitative in vitro diagnostic detection of Bacillus anthracis
JBAIDs Plague Detection Kit BioFire Diagnostics, Inc.
  • Received 06/14/2013
  • Approved 07/31/2013
Modified the previously approved JBAIDS Plague Detection Kit for use with the IT
 1-2-3"1Platinum Path Sample Purification Kit Accessory for the qualitative in vitro diagnostic detection of Yersinia pestis
JBAIDs Tularemia Detection Kit
 
BioFire Diagnostics, Inc.
  • Received 06/27/2013
  • Approved 07/31/2013
Modified the previously approved JBAIDS Tularemia Detection Kit for use with the IT
 1-2-3"1Platinum Path Sample Purification Kit Accessory for the qualitative in vitro diagnostic detection of Francisella tularensis
CDC Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS
 
CDC
  • Received 07/30/2012
  • Approved 08/08/2013

Approved for the quantitation of specific organophosphate metabolites by LC/MS/MS. Measures the concentration of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning
 
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel CDC  
  • Received 12/19/2012
  • Approved 1/14/2013
Modified the previously approved CDC Human Influenza Real-Time RT-PCR Diagnostic Panel to interpret results positive for influenza A H3 and negative for other influenza markers as presumptive positive for H3N2v influenza A virus detection
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel CDC
  • Received 03/04/2013
  • Approved 05/22/2013
Modified the previously approved CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel to allow the use of an alternative enzyme in the assay
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel
 
CDC
  • Received 08/12/2013
  • Approved 09/23/2013
Modified the previously approved CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel to add a new assay for the determination of the genetic lineage of human influenza B virus as B/Victoria or B/Yamagata lineage.  An additional positive control was also added to the panel for use with the new assay
QuickVue Influenza A+B Test Quidel Corporation
  • Received 06/03/2013
  • Approved 06/28/2013
Modified the previously approved QuickVue Influenza A+B to add new analytical reactivity data testing for the influenza A (H7N9) virus
QuickVue Influenza Test Quidel Corporation
  • Received 06/05/2013
  • Approved 07/05/2013
Modified the previously approved QuickVue Influenza to add new analytical reactivity data testing for the influenza A (H7N9) virus
Sofia Influenza A/B FIA Quidel Corporation
  • Received 06/05/2013
  • Approved 07/05/2013
Modified the previously approved Sofia Influenza A/B FIA to add new analytical reactivity data testing for the influenza A (H7N9) virus
Remel Xpect Flu A&B Remel, Inc.
  • Received 06/19/2013
  • Approved 07/12/2013
Modified the previously approved Xpect Influenza A&B to add new analytical reactivity data testing for the influenza A (H7N9) virus
BD Veritor System Flu A+B Assay Clinical Kit Becton, Dickinson and Company
  • Received 07/19/2013
  • Approved 08/07/2013
Modified the previously approved BD Veritor System for the Rapid Detection of Flu A+B to add new analytical reactivity data testing for the influenza A (H7N9) virus
BD Veritor System for Rapid Detection of Flu A+B POC kit Becton, Dickinson and Company
  • Received 07/19/2013
  • Approved 08/07/2013
Modified the previously approved BD Veritor System for the Rapid Detection for Rapid Detection of Flu A+B POC kit to add new analytical reactivity data testing for the influenza A (H7N9) virus
BD Veritor System Flu A+B Assay Becton, Dickinson and Company
  • Received 09/04/2013
  • Approved 10/02/2013
Modified the previously approved BD Veritor System for Rapid Detection of Flu A+B assay to add new analytical reactivity data testing for the H3N2v influenza A virus and  minimal concentration detected for all viruses in the reactivity table
BD Veritor System Flu A+B Assay Becton, Dickinson and Company
  • Received 08/29/2013
  • Approved 09/23/2013
Modified the previously approved BD Veritor System for the Rapid Detection for Rapid Detection of Flu A+B POC kit to new analytical reactivity data testing for the H3N2v influenza A virus and minimal concentration detected for all viruses in the reactivity table
Prodesse ProFlu+ Assay Gen-Probe Prodesse, Inc.
  • Received 07/10/2013
  • Approved 08/09/2013
Modified the previously approved ProFlu+ Assay to add new analytical reactivity data testing for the influenza A (H7N9) virus and modify the internal control
 
Prodesse ProFast+ Assay Gen-Probe Prodesse, Inc.
  • Received 07/30/2013
  • Approved 08/26/2013
Modified the previously approved Prodesse ProFast+ Assay to add new analytical reactivity data testing for the influenza A (H7N9) virus and modify the internal and positive controls
SAS FluAlert A & B Test, SAS Influenza A Test SA Scientific, Ltd.
  • Received 08/02/2013
  • Approved 08/22/2013
Modified the previously approved SAS FluAlert A & B, SAS Influenza A Test to add new analytical reactivity data testing for the influenza A (H7N9) virus
BioSign Flu A + B and Status Flu A & B assays Princeton Biotech Corporation
  • Received 08/13/2013
  • Approved 09/09/2013
Modified the previously approved BioSign Flu A + B and Status Flu A & B assays to add new analytical reactivity data testing for the influenza A (H7N9) virus
Quidel Molecular Influenza A + B Assay Quidel Corporation
  • Received 06/12/2013
  • Approved 08/29/2013
Approved for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection using the Life Technologies QuantStudio Dx Real-Time PCR Instrument
IMDx Flu A/B and RSV for Abbott m2000 Intelligent Medical Devices, Inc.
  • Received 05/31/2013
  • Approved 08/21/2013
Approved for the qualitative determination of influenza A, influenza B, and Respiratory Syncytial Virus Type RNA in nasopharyngeal swabs from patients with signs and symptoms of respiratory infection

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Next section: Appendix 2: Acronyms

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