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.
The article FDA Rejects 2 Gilead Sciences HIV Drugs originally appeared on Fool.com.
Fool contributor Dan Radovsky has no position in any stocks mentioned. The Motley Fool recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
Copyright © 1995 - 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.
