FDA Rejects 2 Gilead Sciences HIV Drugs
Gilead Sciences has received notice from the Food and Drug Administration that it is withholding approval of two drugs meant to be used as part of an HIV treatment regimen, the company announced today.
The FDA wrote Gilead that the reasons for not approving the new drug applications for elvitegravir and cobicistat were observed deficiencies in documentation and the validation of some quality testing procedures and methods.
Gilead Sciences said that though elvitegravir and cobicistat are components of its HIV drug Stribild, the FDA action does not affect the marketing of or continued use of Stribild.
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