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Bristol/Gilead submit Truvada/Sustiva combo

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol-Myers Squibb and Gilead's fixed-dosed combination of Bristol's Sustiva (efavirenz) and Gilead's Truvada (emtricitabine/tenofovir) could be on the market by the first quarter of 2007. Bristol completed the submission of the triple-combo antiretroviral in late April, putting an estimated standard review action date in February 2007. If approved, the combination "would be the first and only product that contains a complete highly active antiretroviral therapy [HIV] regimen in a single once-daily tablet," the firms note. While the sponsors initially ran into bioequivalence issues, they announced in January that they had obtained data supporting bioequivalence (1Pharmaceutical Approvals Monthly January 2006, p. 26)...

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