FDA accepts Gilead's Quad HIV regimen NDA for review

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for the Quad, a complete single-tablet HIV regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.

Gilead 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 (PDUFA) of August 27, 2012.