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New 600 mg tablet strength for Prezista (darunavir)

Food and Drug Administration - February 26, 2008
Richard Klein & Kimberly Struble

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.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


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FD080204

SOURCE: Food and Drug Administration (FDA).

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