Full approval granted for Aptivus


FDA grants full approval of tipranavir.

After receiving accelerated approval in 2005, Boehringer Ingelheim has been granted a full traditional approval for tipranavir (Aptivus). The FDA action was based on results from RESIST, two ongoing phase III clinical trials. Tipranavir is a protease inhibitor (PI) that should be coadministered with 200 mg ritonavir and is indicated as part of combination antiretroviral treatment of HIV-1 infected adult patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one PI.

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