FDA finalizes 5-year exclusivity for NCE combos

FDA issued Gilead Sciences Inc. (NASDAQ:GILD) submitted a Citizen's Petition asking the agency to recognize five years of exclusivity for the company's newly approved HIV drug Stribild, a once-daily tablet comprising two NCEs, elvitegravir and cobicistat, along with the company's Truvada emtricitabine/tenofovir.

FDA denied Gilead's petition and two other CPs submitted when it issued the draft guidance last year. ...