Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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Food and Drug Administration - October 2, 2008
On September 30, 2008, FDA approved an alternative dosing regimen for Reyataz (atazanavir) for HIV-1 infected treatment-naive patients who can take ritonavir. The recommended dosage is Reyataz 300 mg with ritonavir 100 mg once daily for treatment-naive patients. Revisions with respect to the new dosing regimen in treatment-naive patients were added to the package insert. Other minor revisions were made throughout the label.
The revised label can be found at http://www.fda.gov/cder/foi/label/2008/021567s017lbl.pdf. A highlighted version of the complete label showing the specific changes is available at http://www.fda.gov/medwatch/safety/2008/sep08.htm#Reyataz.
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
081002
FD081001
SOURCE: Food and Drug Administration (FDA).
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