Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
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Food and Drug Administration - April 23, 2007
Richard Klein & Kimberly Struble
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 provided in the pdf attached file.
Richard Klein | Office of Special Health Issues | Food and Drug Administration
Kimberly Struble | Division of Antiviral Drug Products | Food and Drug Administration
070423
FD070404
SOURCE: Food and Drug Administration (FDA).
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