FDA: Termination of Declarations of Emergency Justifying Emergency Use Authorization (EUA) of Certain Antiviral Drugs - Zanamivir, Oseltamivir Phosphate, and Peramivir
ROCKVILLE, Md., June 23, 2010--The FDA has posted on its web site letters that announce the termination of declarations for the emergency use antiviral drugs Zanamivir, Oseltamivir Phosphate, and Peramivir. The declarations described will terminate when the Public Health Emergency determination for 2009 H1N1 influenza expires on June 23, 2010.
Food and Drug Administration
Silver Spring MD 20993
June 21, 2010
Thomas R. Frieden, MD, MPH
Director
Centers for Disease Control and Prevention
1600 Clifton Rd., MS D-14
Atlanta, GA 30333
Re: Termination of Declarations of Emergency Justifying
Emergency
Use Authorization (EUA) of Certain Antiviral Drugs—Zanamivir,
Oseltamivir Phosphate, and Peramivir
Dear Dr. Frieden:
This letter is to provide advance notice of the termination of:
(1) the declaration of emergency that was issued by the then Acting Secretary of the Department of Health and Human Services (HHS) Charles E. Johnson on April 26, 2009, pursuant to section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 360bbb-3, justifying the authorization of the emergency use of certain products from the neuraminidase class of antivirals Oseltamivir Phosphate and Zanamivir; and
(2) the declaration of emergency that was issued by the Secretary
of HHS on October 20, 2009, pursuant to section 564(b)(1) of the
Act, 21 U.S.C. § 360bbb-3, justifying the authorization of the
emergency use of the antiviral peramivir.
Both of the declarations described above will terminate when the
Public Health Emergency determination for 2009 H1N1 influenza
expires on June 23, 2010. Therefore, after June 23, 2010, the EUA
authorizing the unapproved uses of zanamivir and oseltamivir
phosphate and the use of the unapproved drug peramivir will no
longer be in effect. For any patient who began a treatment course
of peramivir prior to June 23, 2010, the authorization shall
continue to be effective after June 23, 2010, to allow completion
of that treatment course, to the extent the patient's attending
physician finds continued treatment necessary. 21 U.S.C. §
360bbb-3(f)(2).
The advance notice of termination will be published in the Federal
Register, pursuant to section 564(b)(4) of the Act, 21 U.S.C.
§ 360bbb-3(b)(4).
Sincerely,
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Posted: June 2010
