Gilead/Bristol Truvada/Sustiva combo delay
This article was originally published in Pharmaceutical Approvals Monthly
Gilead and Bristol-Myers Squibb's NDA for a Sustiva (efavirenz)/Truvada (emtricitabine/tenofovir) fixed dose combination is delayed until the first half of 2006 after the firms' initial formulation fails to demonstrate bioequivalence to the individual component drugs. Gilead announced the negative results for the initial study Aug. 9. However, the firms are "proceeding with the evaluation of up to three new formulations," Gilead says. Gilead previously had projected an NDA submission in the second half of 2005...
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