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Bristol-Myers Squibb, Gilead submit NDA for Sustiva, Truvada for HIV treatment

Published in AIDS Weekly, June 5th, 2006

Bristol-Myers Squibb Company (BMY) and Gilead Sciences, Inc., (GILD) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of a product that combines the anti-HIV medications Sustiva (efavirenz), manufactured by Bristol-Myers Squibb, and Truvada (emtricitabine and tenofovir disoproxil fumarate), manufactured by Gilead Sciences, in a once-daily single tablet regimen.

Truvada itself is a fixed-dose product that contains two of Gilead's anti-HIV medications, Viread (tenofovir disoproxil fumarate) and Emtriva (emtricitabine), in a single once-daily tablet. If approved by the FDA, the new single tablet regimen...

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