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Gilead under investigation over manufacture of drugs

Daily News | June 13, 2011

Kevin Grogan

Gilead under investigation over manufacture of drugs

Gilead Sciences has received a subpoena from the US Department of Justice related to "the manufacture, and related quality and distribution practices" of most of its products.

The subpoena from the US Attorney’s Office for the Northern District of California requesting documents about Gilead's AIDS drugs Emtriva (emtricitabine), Viread (tenofovir), Truvada (tenofovir/emtricitabine) and Atripla, which combines Truvada with Bristol-Myers Squibb’s Sustiva (efavirenz).

The US authorities also want information on the company's investigational fixed-dose combination of Truvada and Johnson & Johnson’s recently-approved HIV drug Edurant (rilpivirine), plus the hepatitis B drug Hepsera (adefovir) and its pulmonary arterial hypertension compound Letairis (ambrisentan).

Gilead has not provided any other details, simply stating that it is "cooperating in this civil and criminal investigation". However, last September, the California-headquartered firm got a warning letter from the US Food and Drug Administration which identified "significant violations" of current Good Manufacturing Practice at its San Dimas facility.

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