FOSTER CITY (dpa-AFX) - Gilead Sciences Inc. (GILD) announced that the U.S. Food and Drug Administration has accepted for review the New Drug Application or NDA for the Quad, a complete single-tablet HIV regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.
Gilead said that it submitted the Quad NDA on October 27, 2011. The FDA has set a target review date for the Quad under the Prescription Drug User Fee Act of August 27, 2012.
Elvitegravir is an integrase inhibitor. Elvitegravir was licensed by Gilead from Japan Tobacco or JT in March 2005. Under the terms of Gilead's agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights.
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