HIV/AIDS Therapy

U.S. FDA approves 500 mg HIV protease inhibitor to use with antiretrovirals

Published in Medical Letter on the CDC and FDA, January 23rd, 2005

Roche announced U.S. Food and Drug Administration (FDA) approval of a new 500 mg film-coated tablet formulation of its HIV protease inhibitor Invirase (saquinavir mesylate), designed for use in combination with a small dose of ritonavir and other anti-HIV drugs for the treatment of HIV infection.

The new formulation of Invarse, which was approved under a 6-month priority FDA review, will reduce pill count for each dose by more than half (from 5 pills to 2, twice-daily) compared to the current formulation of Invirase 200 mg capsules.

The approval was based on data that show similar drug levels are achieved with Invirase 500 mg tablets and Invirase 200...

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Source: Medical Letter on the CDC and FDA (2005-01-23)

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