Content on this page was developed during the 2009-2010 H1N1 pandemic and has not been updated.
- The H1N1 virus that caused that pandemic is now a regular human flu virus and continues to circulate seasonally worldwide.
- The English language content on this website is being archived for historic and reference purposes only.
- For current, updated information on seasonal flu, including information about H1N1, see the CDC Seasonal Flu website.
Termination of the Emergency Use Authorization (EUA) of Medical Products and Devices
Site last updated June 24, 2010 10:00 AM ETPer 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
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