Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information; Availability

摘要

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for peramivir 200 milligrams (mg)/20 milliliter (mL) (10 mg/mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst) for intravenous (IV) administration in certain adult and pediatric patients. Peramivir is a drug that is not approved by FDA. FDA is issuing the Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of peramivir. The Authorization follows the determination by then Acting Secretary of the U.S. Department of Health and Human Services Charles E. Johnson (then Acting Secretary) that a public health emergency exists involving Swine Influenza A (now known as "2009-H1N1 Influenza") that affects, or has the significant potential to affect, national security. The determination has been renewed. On the basis of such determination, the Secretary declared an emergency justifying the authorization of the emergency use of the antiviral peramivir, accompanied by emergency