Bristol-Myers Squibb, Gilead Submit HIV NDA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Bristol-Myers Squibb and Gilead Sciences have submitted an NDA to the FDA for a product that combines the anti-HIV medications Sustiva (BMS) and Truvada (Gilead) in a once-daily single tablet regimen. Truvada itself is a fixed-dose product that contains two of Gilead’s anti-HIV medications, Viread and Emtriva, in a single once-daily tablet. If approved by the FDA, the new single tablet regimen would be the first and only product that contains a complete Highly Active Antiretroviral Ther...

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