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FDA Announces Atazanavir Labeling Changes
Author:佚名    InfoSource:pharmalive.com    Hits:    Update Time:2006-2-3 Recommend

ROCKVILLE, Md., Jan. 27, 2006--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.

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> Richard Klein Office of Special Health Issues Food and Drug Administration

Kimberly Struble Division of Antiviral Drug Products Food and Drug Administration

An archive of past list serve announcements is available on the FDA web site at http://www.fda.gov/oashi/aids/listserve/archive.html <http://www.fda.gov/oashi/aids/listserve/archive.html>

Contact: 1-888-INFO-FDA (1-888-463-6332) -- main FDA Phone Number (for general inquiries)


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