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 TheBody.com: 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.