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

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

The Food and Drug Administration (FDA) is announcing an amendment to the Emergency Use Authorization (EUA) (the Authorization) for peramivir injection 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 issued on October 23, 2009, under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). FDA received inquiries related to the recommended dosing for patients with renal impairment. On November 19, 2009, FDA amended the Authorization letter and reissued the Authorization letter in its entirety to provide additional clarification. The Authorization letter, as amended and reissued, which includes explanations for its reissuance, is reprinted in this notice.

DATES: The amended Authorization is effective as of November 19, 2009.

 

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