2 HIV drugs from Gilead's Stribild fail to win FDA approval as standalones

04/30/2013 | MedCityNews.com

The FDA turned down Gilead Sciences' regulatory applications for elvitegravir and cobicistat as standalone treatments for HIV, citing problems in certain quality testing procedures. The two drugs are included in Gilead's 4-in-1 HIV pill Stribild, which was approved by the FDA last year. Gilead says it is working with the agency to address the issues mentioned in the rejection letter.

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