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U.S. Department of Health and Human Services

For Consumers

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Atazanavir labeling changes

Updates to the REYATAZ (atazanavir sulfate) package insert were approved on January 25, 2006, to reflect new in vitro inhibition data and clinical drug-drug interaction information regarding coadministration of atazanavir and/or atazanavir/ritonavir with proton pump inhibitors, H2 receptor antagonists, methadone, rifampin, enteric-coated didanosine and tenofovir.

A summary of the changes to the package insert is provided in the attached pdf file.

The complete revised label is available at http://www.fda.govhttp://www.accessdata.fda.gov/drugsatfda_docs/label/ 2006/021567s007lbl.pdf

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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