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U.S. Department of Health and Human Services

For Consumers

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Updated Kaletra Labeling

Product labeling for KALETRA lopinavir/ritonavir)has been updated to reflect safety and efficacy data from study M97-720 in treatment-naïve patients out to 360 weeks. Kaletra is manufactured by Abbott Laboratories, North Chicago, IL.

The complete revised product labeling is available through Drugs@FDA.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration