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Termination of the Emergency Use Authorization (EUA) of Medical Products and Devices
This website is archived for historical purposes and is no longer being maintained or updated. For updated information on the 2011-2012 flu season, see the CDC Seasonal Flu website.
Per the FDA-issued advance notice letters listed below, the declaration of Public Health Emergency determination for 2009 H1N1 Influenza expired on June 23, 2010.
- Termination of Declarations of Emergency Justifying EUA of Certain Antiviral Drugs: Tamiflu (oseltamivir phosphate), Relenza (zanamivir), and Peramivir
- Termination of Declaration of Emergency Justifying the Authorization of Emergency Use of Certain Personal Respiratory Protection Devices
- Termination of Declaration of Emergency Justifying EUA of Certain In Vitro Diagnostic Tests
Information regarding Termination and Disposition of CDC-requested and FDA-issued EUA Products:
Antiviral Drugs:
- Relenza (zanamivir) and Tamiflu (oseltamivir)
- Disposition Letter for Relenza and Tamiflu
- Attachment 1 to the Disposition Letter for Relenza and Tamiflu: Questions and Answers Regarding Termination of the Emergency Use Authorizations (EUAs) for Tamiflu (oseltamivir) and Relenza (zanamivir)
- Attachment 2 to the Disposition Letter for Relenza and Tamiflu:Update regarding Stockpiled Antivirals at or Nearing Expiration
- Peramivir IV
Devices:
- N95 Respirators
For questions regarding EUAs, contact:EUA.OCET@fda.hhs.gov
Last syndicated: March 19, 2012 10:10 PM EDT
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