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FDA rebukes Abbott over Kaletra, again

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WASHINGTON, Nov 03, 2004 (United Press International via COMTEX) -- The U.S. Food and Drug Administration is accusing Abbott Laboratories of false and misleading marketing of an HIV/AIDS drug.

Abbott makes Kaletra, the nation's most popular protease inhibitor for people with human immunodeficiency virus, the Chicago Tribune reported.

The FDA's accusation, the second in six months, claims that Abbott is exaggerating the drug's benefits and minimizing its risks.

Kaletra has become a blockbuster for Abbott since it won U.S. approval four years ago. It is projected to generate more than $800 million in worldwide sales this year.

The drug blocks an enzyme and appears to stop HIV from reproducing and spreading in the body.

Copyright 2004 by United Press International.

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