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Traditional approval of Aptivus (tipranavir)

On October 4, 2007, FDA granted traditional approval to Aptivus (tipranavir), for combination antiretroviral treatment of HIV-1 infected adults with evidence of viral replication, who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor. Aptivus was granted accelerated approval on June 22, 2005, based on analysis of plasma HIV-1 RNA levels in two controlled phase 3 studies of 24 weeks duration of Aptivus/ritonavir. The traditional approval is based on continuation of the RESIST trials through 48 weeks and beyond, confirming durability of the virologic response. Aptivus is a product of Bohringer Ingelheim.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/09/2014
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