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Atazanavir labeling changes

Food and Drug Administration - January 25, 2006
Richard Klein & Kimberly Struble

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.

Acrobat ReaderDownload PDF Summary of Label Changes

The complete revised label for Reyataz can be viewed at:

Acrobat ReaderDownload PDF of Complete Revised Label

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


060125
FD060102

SOURCE: Food and Drug Administration (FDA).

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