Press Release

New 600-mg Tablet Strength for Prezista (Darunavir)

February 26, 2008

On February 25, 2008, FDA approved a new 600-mg tablet strength for Prezista (darunavir), manufactured by Tibotec, Inc., Yardley, PA. The new 600-mg tablet facilitates dosing by reducing pill burden.

The recommended oral dose of Prezista tablets is 600 mg (two 300-mg tablets or one 600-mg tablet) twice daily taken with ritonavir 100 mg twice daily and with food.

The 600-mg formulation will be available in bottles of 60 tablets.

The 300-mg tablet will continue to be available.

Darunavir is a protease inhibitor, which inhibits the formation of mature virus in HIV infected cells.

[Editor's note from The 600-mg tablet is not expected to be available in the United States until mid-May 2008, according to a Tibotec official. The official also noted that the price of the new tablet will be the same as two of the 300-mg tablets.]

This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.


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