Tibotec Files NNRTI Rilpivirine, Part Of Gilead's New Combo For HIV
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Johnson & Johnson subsidiary Tibotec has submitted its once-daily non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine) for treatment-naïve HIV patients for FDA approval, close on the heels of releasing pivotal data at the International AIDS Society meeting in Vienna
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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.
Gilead Files Next HIV Triple-Combo Pill, With Hopes Of Prophylaxis Claim; Can Firm Recreate HIV Success In Hep C?
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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