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FDA approves Gilead's Tybost, Vitekta

October 4, 2014 1:58 AM UTC

FDA approved two resubmitted NDAs from Gilead Sciences Inc. (NASDAQ:GILD) in advance of this week's PDUFA dates for both HIV compounds.

On Sept. 24, the agency approved Tybost cobicistat, an inhibitor of cytochrome P450 family 3 subfamily A ( CYP3A), as a boosting agent for HIV treatment with protease inhibitors atazanavir and darunavir and other antiretroviral agents. The PDUFA date was Oct. 3. Gilead will begin marketing Tybost in the U.S. within two weeks. ...