FDA Approves Emergency Rules for Antiviral Drugs - @ JEMS.com


FDA Approves Emergency Rules for Antiviral Drugs


 
 

| Tuesday, April 28, 2009


WASHINGTON (AP) -- The Food and Drug Administration has issued emergency guidance that allows certain antiviral drugs to be used in a broader range of the population in case mass dosing is needed to deal with a widespread swine flu outbreak.

The agency originally approved the use of the antiviral drug Tamiflu for the prevention and treatment of influenza in adults and children age 1 and older. Another antiviral drug, Relenza, was originally approved to treat people 7 and older and to help prevent flu in those 5 and older.

Late Monday, the FDA said it issued emergency guidance to allow Tamiflu to treat and prevent flu in children under 1 and to provide doses other than originally approved in children over 1. The drugs may be distributed to larger segments of the population without complying with the approved label requirements, the FDA said. The agency also authorized a swine flu diagnostic test for testing samples from people with certain flu infections - those whose virus subtypes cannot be identified by currently available tests.




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