HIV/AIDS
Gilead Finalizes Selection of Bioequivalent Formulation for the Fixed-Dose Regimen of Truvada(R) and Tibotec Pharmaceuticals' TMC278
Published in Medical Letter on the CDC and FDA, May 16th, 2010
Gilead Sciences, Inc. (Nasdaq:GILD) announced it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg). A bioequivalence study is required to demonstrate that a co-formulated product results in the same levels of medication in the blood as achieved when the individual products are dosed simultaneously as separate pills. Gilead anticipates submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the fixed-dose...
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