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Gilead Files Next HIV Triple-Combo Pill, With Hopes Of Prophylaxis Claim; Can Firm Recreate HIV Success In Hep C?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Gilead Sciences, Inc. has filed an NDA for a triple-combination HIV pill that could supplant its existing Atripla, which will face generic pressure in 2013. The company announced Nov. 23 that it has filed for FDA approval of a single-tablet regimen containing its Truvada (emtricitabine/tenofovir) plus Johnson & Johnson's investigational non-nucleoside reverse transcriptase inhibitor rilpivirine, also known as TMC278.

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