FOSTER CITY, Calif. — Gilead Sciences Inc. said Monday that the Food and Drug Administration rejected two marketing applications for HIV treatments, citing quality control problems at the company’s manufacturing facilities.
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 news release it is working to address the issues raised by the agency. A company representative said in an email that Gilead would not provide further details on the issue.
Gilead a sked the FDA to approve the drugs as stand-alone treatments in June. The company is also seeking approval in Europe.
Its shares fell 19 cents to $51.19 in trading Monday. Its shares peaked for the past year at $55.16 last Tuesday. They traded as low as $24.12 in early June 2012.
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