FDA issues emergency swine flu orders

WASHINGTON, April 28 (UPI) -- The U.S. Food and Drug Administration says it has issued emergency orders making diagnostic tools and certain drugs available to fight the swine flu outbreak.

The FDA said it initiated the emergency-use authorizations in response to requests from the U.S. Centers for Disease Control and Prevention for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test.

The EUA authority allows the FDA to authorize the use of unapproved or uncleared medical products following a declaration of emergency, provided certain criteria are met, the agency said in a statement. "The authorization will end when the declaration of emergency is terminated or the authorization (is) revoked by the agency."

Relenza is now approved only to treat acute uncomplicated illnesses due to influenza in adults and children 7 and older, and for the prevention of influenza in adults and children 5 and older. Tamiflu is approved for the treatment and prevention of influenza in patients 1 year and older.

Under the emergency action, Tamiflu may also be used to treat and prevent influenza in children under 1 year, and to provide alternate dosing recommendations for children older than 1 year. In addition, both medications may be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs.