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FDA rejects 2 HIV drugs from Gilead Sciences

FOSTER CITY, Calif. — Gilead Sciences Inc. says that the Food and Drug Administration rejected two marketing applications for HIV treatments, citing quality control problems at the company’s manufacturing facilities.

The FDA informed the company in a letter that it cannot approve its HIV pills elvitegravir and cobicistat for use in managing the virus that causes AIDS.

The agency noted that in recent inspections regulators have found problems with documentations and quality testing at Gilead Sciences’ facilities.

The company said in a release it is working to address the issues raised by the agency.



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