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Quality issues hang up Gilead elvitegravir, cobicistat NDAs

This article was originally published in Scrip

Executive Summary

While the FDA had no problem approving Gilead's elvitegravir and cobicistat as components of the company's once-daily four-in-one treatment for HIV infection, Stribild (emtricitabine, tenofovir disoproxil fumarate, evitegravir and cobicistat), regulators rejected the individual new drug applications (NDAs) for those agents, the firm revealed on 29 April.



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