Amended Authorizations of Emergency Use of Zanamivir, Oseltamivir Phosphate, and Peramivir; Authorization of Emergency Use of Certain In Vitro Diagnostic Devices; Availability; Notices

• Date: May 04, 2010
• Source: www.fda.gov

The Food and Drug Administration (FDA) is announcing amendments to the two Emergency Use Authorizations (EUAs) (the Authorizations) for certain products from the neuraminidase class of antivirals, zanamivir and oseltamivir phosphate, issued on April 27, 2009, under the Federal Food, Drug,  and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). On  July 14, 2009, in response to a request from CDC, FDA amended and reissued in its entirety the Authorization for certain oseltamivir phosphate products. On October 30, 2009, in response to a request   from CDC, among other reasons, FDA amended and reissued in their entirety the Authorization letters for certain zanamivir and oseltamivir phosphate products. Finally, on November 4, 2009, FDA amended and reissued in its entirety the Authorization letter for certain zanamivir inhalation powder. The Authorization letter for certain oseltamivir phosphate products, as amended on October 30, 2009, and the Authorization letter for certain zanamivir inhalation powder, as amended on November 4, 2009, including explanations for their reissuance, are reprinted in this document.

DATES: The amended Authorizations are effective as of October 30, 2009.

 

Click here to download the file